Program

The 22nd Annual Scientific Meeting of the Heart Failure Society of America will be held on Saturday, September 15, through Tuesday, September 18, 2018 at the Gaylord Opryland in Nashville, TN.

Target Audience: HFSA’s Annual Scientific Meeting is intended for physicians, nurses, nurse practitioners, pharmacists,  scientists, and health care professionals who specialize or have an interest  in heart failure.

Note: Program is subject to change and will be updated continuously up to the conference.

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Meeting Application Supported by Cytokinetics

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Meeting Highlights
Satellite Symposia (CME)
Industry Expert Theaters (Non-CME)
Contemporary Forums (Non-CME)
Clinical Trial Row

Meeting Highlights 

Satellite Symposia (CME)

Saturday, September 15, 2018
Sunday, September 16, 2018
MONDAY, September 17, 2018

Industry Expert Theaters (Non-CME)

Saturday, September 15, 2018
  • Iron Deficiency Anemia (IDA) in Patients with Heart Failure
    6:15 PM – 7:15 PM CDT
    Sponsored by Daiichi Sankyo
    Details
    Faculty
    Nassir Azimi, MD
    Description
    The program will address the following:
    •  Types of patients who can have iron deficiency anemia (IDA) and its prevalence
    •  Pathophysiology, causes and consequences of IDA
    •  Impact of IDA in patients with heart failure
    • Differential diagnosis of IDA using laboratory assessments, signs and symptoms
    • The treatment goals and available treatments for IDA
    • Efficacy and safety of Injectafer® (ferric carboxymaltose injection) in patients with IDA
Sunday, September 16, 2018
  • Bridging Perspectives: Insights on Cardiorenal Interactions in Patients With Heart Failure
    12:00 PM – 1:00 PM CDT
    Sponsored by Novartis Pharmaceuticals Corporation
    Details
    Faculty
    Jeffrey Testani, MD, MTR
    Hamid Moradi MD, FACP, FASN
    Description
    In both chronic heart failure and episodes of acute decompensation, cardiac and renal pathophysiologic mechanisms interact bidirectionally, resulting in altered hemodynamics, activation of the renin angiotensin-aldosterone system and sympathetic nervous system, and reduced effectiveness of the natriuretic peptide system. Renal dysfunction is common in patients with heart failure, and therefore thoughtful management of cardiorenal interactions is important for the prevention of further organ dysfunction and disease progression. This program will review cardiorenal interactions in the pathophysiology of heart failure from the perspective of both a cardiologist and nephrologist, discuss the management of cardiorenal syndrome in inpatient and outpatient settings, and highlight the importance of multidisciplinary care for patients with heart failure and kidney dysfunction.
  • Considering Heart Rate in Managing HF Hospitalization
    1:30 PM – 2:00 PM CDT
    Sponsored by Amgen
    Details
    Faculty
    Gregg C. Fonarow, MD, FHFSA
    Description
    Disease state education on considering heart rate in managing heart failure hospitalization.
  • Recognizing the Unfamiliar in the Familiar: Making the Differential Diagnosis of Hereditary ATTR Amyloidosis
    5:15 PM – 6:15 PM CDT
    Supported by Akcea Therapeutics
    Details
    Join Dr. Mazen Hanna, Chair, Dr. Martha Grogan, Dr. Mathew Maurer and Dr. Jim Dyck for this one-hour Industry Expert Theater exploring key topics in hereditary ATTR amyloidosis (hATTR). This program will highlight the challenges in diagnosis due to the range of non-specific symptoms associated with this disease, the need to make a differential diagnosis of hATTR amongst more common cardiac conditions, and the need for a multidisciplinary management approach including a thorough evaluation of neuropathy in patients with cardiac involvement. Stop by Akcea booth #219 for more information!
    Presenters:

    Mazen Hanna, MD
    Cleveland Clinic
    Cleveland, OH

    Martha Grogan, MD
    Mayo Clinic
    Rochester, MN

    Mathew Maurer, MD
    Columbia University
    New York, NY

    P. James B. Dyck, MD
    Mayo Clinic
    Rochester, MN

Monday, September 17, 2018
  • hATTR Amyloidosis: A Disease State Overview & Diagnostic Challenges
    10:00 AM – 10:30 AM CDT
    Sponsored by Alnylam Pharmaceuticals
    Details
    Faculty
    Dan Jacoby, MD
    Yale New Haven Medical Center
    Description
    hATTR Amyloidosis is a rare, genetically inherited, debilitating, life-threatening disease that affects an estimated 50,000 individuals world-wide. This program will provide an overview of hATTR amyloidosis, describe the multi-systemic manifestations of the disease, and review the diagnostic challenges to arrive at an accurate diagnosis.
  • HFrEF and Sudden Cardiac Death: Insights from a Large HF Outcome Study
    12:00 PM – 1:00 PM CDT
    Sponsored by Novartis Pharmaceuticals Corporation
    Details
    Faculty
    Richard Wright, MD, FACC
    Description
    Current understanding of heart failure pathophysiology suggests that an imbalance in the neurohormonal systems drives development and progression of heart failure. Although there are evidence-based pharmacologic therapies that target the sympathetic nervous system or the renin-angiotensin-aldosterone system, morbidity and mortality associated with heart failure with reduced ejection fraction (HFrEF) remain high. Please join us as medical experts engage in discussions on the mechanism of action of a novel HFrEF therapy and its landmark clinical trial data. This session will also allow for the practical application of the HF guideline and clinical study findings through the use of an interactive patient case study.
 

Contemporary Forums (Non-CME)

Saturday, September 15, 2018
  • 3rd Annual “Managing the Economics in the Treatment of Heart Failure”
    8:00 AM – 10:00 AM CDT | Tennessee C
    Sponsored by Cytokinetics
    Details
    Description: Our distinguished faculty will present, discuss and engage the audience on many issues relevant to the care for patients with heart failure in modern practice. Discussion topics will include recent public policy initiatives and their impact on outcomes, cost and quality of care, the assessment of the utilization and financial impact of new therapies, the evolution of payment models, and socioeconomic barriers to optimal management of heart failure in the real world.
    • Appreciate the latest policy initiatives aimed at improved outcomes and reducing cost of heart failure (HF)
    • Discuss the appropriate assessment of hospital readmissions in patients with HF
    • Assess the clinical and health economic impact of new therapies for HF
    • Review the payment models and readmission reduction programs in HF
    • Discuss the role of patients and primary care physicians in the management of HF

    Agenda
    Introduction and Program Overview
    Ileana L. Pina, MD, MPH, Associate Chief of Academic Affairs
    Montefiore Medical Center, Bronx, NY

    Current and Future Public Policy Initiatives in HF: New Data on Efforts to Improve Costs and Outcomes
    Nihar R. Desai, MD, MPH, Assistant Professor of Medicine
    Yale School of Medicine, Center for Outcomes Research and Evaluation, New Haven, CT

    Hospital Readmissions in HF: Are We Measuring the Right Metric?
    Larry Allen, MD, Associate Professor, Medicine – Cardiology
    University of Colorado Hospital (UCH), Aurora, CO

    Update on Utilization and Financial Impact of New Heart Failure Therapies: Impact of the MACRA One Year Later
    Paul A. Heidernreich, MD, MS, Professor and Vice-Chair, Department of Medicine
    Stanford University School of Medicine, Stanford, CA

    Readmission Reductions Program and Payment Models: The CMS Perspective
    Speaker TBD

    Questions and Answers from the Audience: Faculty Panel Discussions

  • The Use of MCS in Cardiogenic Shock Patients
    12:15 PM – 1:15 PM CDT | Tennessee C
    Supported by Abiomed
    Details
    Description: This lunch symposium will highlight the importance of timing and type of use of percutaneous mechanical circulatory support devices for patients with cardiogenic shock. The program will describe strategies for solving the hemodynamic equation, developing algorithms for the heart team and will demonstrate how early support can lead to improved outcomes through case presentations.

    Agenda
    12:15 pm – Transvalvular Continuous Flow Pumps as a Preferred Strategy for Solving the Hemodynamic Equation, Dan Burkhoff, MD

    12:35 pm – The Heart Team Approach to Algorithms and MCS of Escalating Care in a Collaborative Approach to Patient Treatment, Shelley Hall, MD, FHFSA

    12:55 pm – Case Presentations
    • Combining Support Devices: EcPella (Using ECMO and Impella Simultaneously), Jaime Hernandez-Montfort, MD, MPH, FHFSA
    • Identifying RV Failure after LVAD Support: Using Impella RP as a Treatment Strategy, Ajay Srivastava, MD 

  • ReDS: Non-invasive Fluid Management for Heart Failure Patients Across the Continuum of Care
    7:30 PM – 9:00 PM CDT | Presidential A
    Supported by Sensible Medical
    Details
    Description: Panel discussion & dinner chaired by Dr. Daniel Burkhoff featuring data on the reduction of heart failure readmission and building of a successful HF program with Remote Dielectric Sensing (ReDS). Discussion will follow on actionable lung fluid volume data enabled by ReDS technology across the continuum of care and its relation to invasive hemodynamics.

    Faculty
    William Abraham, MD
    Daniel Bensimhon, MD
    Daniel Burkhoff, MD, PhD
    Scott Feitell, DO
    Sean Pinney, MD
    Nir Uriel, MD, MSc

Sunday, September 16, 2018
  • Are We Doing Enough to Manage Hyperkalemia in Our Patients with Heart Failure?
    6:45 AM – 7:45 AM CDT | Presidential A
    Supported by Relypsa
    Details
    Description: Hyperkalemia is potentially life threatening, and is often undetected until patients exhibit serious consequences, such as arrhythmia, the risk of which is already elevated in heart failure. Renal deficiency is common in patients with heart failure, and, along with the use of renin-angiotensin-aldosterone system inhibitors, further increases the risk of hyperkalemia. This presentation will explore the pathophysiology and outcomes of hyperkalemia in heart failure and discuss a novel treatment to manage hyperkalemia.

    Faculty: Javed Butler, MD, Professor and Chairman, Department of Medicine, UMMC

  • HeartLogic™ Heart Failure Diagnostic – Clinical Evidence and Practical Consideration
    6:45 AM – 7:45 AM CDT | Presidential B
    Supported by Boston Scientific
    Details
    Faculty:

    John P. Boehmer, MD
    Professor of Medicine, Penn State College of Medicine
    Heart Failure Program Director, Penn State Milton S. Hershey Medical Center
    Hershey, PA

    Marie Galvao, MSN, ANP-BC, CHFN
    Center for Advanced Cardiac Therapy
    Montefiore Medical Center
    Bronx, NY

    Seth J. Rials, MD, PhD
    Medical Director of Arrhythmia Services, Grant Medical Center
    OhioHealth Heart and Vascular Physicians
    Columbus, OH

    Moderator:
    JoAnn Lindenfeld, MD
    Director, Advanced Heart Failure/Cardiac Transplantation
    Vanderbilt University Medical Center
    Nashville, TN

    Description:
    The recently approved HeartLogic™ Heart Failure Diagnostic, exclusively in Boston Scientific implantable defibrillators and CRT-Ds, continually measures heart sounds, respirations, thoracic impedance, heart rates, and patient activity to calculate an Index of worsening heart failure status and can provide an alert through remote monitoring. Experts will discuss clinical data supporting the HeartLogic diagnostic, share early experience with HeartLogic alerts, how HeartLogic can help risk stratify patients and provide best practices to integrate HeartLogic into heart failure clinical practice.

Monday, September 17
  • Improving Heart Failure Patient Care Across the Continuum
    7:15 AM – 8:15 AM CDT | Presidential A
    Supported by Medtronic 
    Details
    Description: This session will incorporate CRT and LVAD therapy discussion, as well as managing Mitral Regurgitation patients. Case based discussions along with appropriate use of both therapies.

    Faculty:
    Marc Silver, MD, FHFSA
    Jeffrey Teuteberg, MD
    Nir Uriel, MD

    Agenda
    Utilizing a Guideline-Based Approach to Cardiac Resynchronization Therapy, Marc Silver, MD, FHFSA
    Expand Indications for Left Ventricular Assist Devices, Jeffrey Teuteberg, MD
    Rationale for Correcting Secondary Mitral Regurgitation and Novel Transcatheter Solutions, Nir Uriel, MD

Clinical Trial Row

  • CTR- 401
    Macitentan in Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease
    Details
    Acronym: SERENADEI/AC-055G202
    Supporter: Actelion Pharmaceuticals, Ltd
    Description: SERENADE/AC-055G202INCTO31S3111Amulti-center,double-blind,placebo controlled Phase2 b study to evaluate the efficacy and safety of macitentanin subjects with heartfailure with preserved ejection fraction and pulmonary vascular disease.
  • CTR- 402
    A PHASE 3, MULTINATIONAL, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF ARRY-371797 IN PATIENTS WITH SYMPTOMATIC DILATED CARDIOMYOPATHY DUE TO A LAMIN A/C GENE MUTATION
    Details
    Acronym: N/A
    Supporter: Array BioPharma Inc
    Description: This multinational Phase 3 study will evaluate the efficacy, safety and PK following treatment with ARRY-371797 compared with placebo (1:1 randomization) in approximately 120 patients with NYHA functional Class II and III genetic DCM secondary to LMNA mutations. NYHA functional Class IV patients (up to approximately 40) will also be enrolled (1:1 randomization) and will be assessed for overall safety, as well as PK, PD and efficacy, if feasible. The primary objectiveis to valuate the effect of ARRY-371797 on functional capacity as measured by the 6 minute walk test compared to placebo. Secondary objectives include evaluating additional measure of efficacy (NT-proBNP, KOL assessments), pharmacokinetics and safety, including hospitalization free-survival (HFS) and overall survival. The study will further evaluate a dose level of ARRY-371797 that has shown preliminary efficacy and safety in this patient population.

    The study will be conducted in 2 parts: a randomized, double-blind treatment period for at least 24 weeks followed by an ARRY 371797 open-label treatment period. Study drug treatment received in the randomized period will remain blinded for all patients until the primary analysis is performed and a mature evaluation of hospitalization (HFS) and mortality has been completed, after which treatments will be unblinded and patients receiving placebo may initiate treatment with ARRY 371797 provided eligibility criteria are met.

  • CTR-403
    A Novel Phase 2 Study of Vericiguat in Heart Failure with Preserved Ejection Fraction (VITALITY-HFpEF)
    Details
    Acronym: VITALITY-HFpEF
    Supporter: Bayer and Merck
    Description: Vericiguat is an oral soluble guanylate cyclase (sGC) stimulator developed for chronic heart failure (HF). Whereas the Phase IIb SOCRATES-PRESERVED trial in HF with preserved ejection fraction (HFpEF) did not meet the primary endpoints NT-proBNP or LA volume change, pts in the 10 mg vericiguat arm experienced more pronounced improvement in health related quality of life, physical limitations and NYHA class. We hypothesize vericiguat improves physical functioning assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Physical Limitation Score (PLS) in HFpEF pts treated for 24 weeks. Aims: 1] To evaluate the efficacy of vericiguat 10 mg in comparison to placebo on improving physical functioning from baseline to week 24; 2] to evaluate the efficacy of vericiguat 15 mg in comparison to placebo on improving physical functioning from baseline to week 24; and 3] to evaluate the safety and tolerability of vericiguat.
  • CTR-404
    Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)
    Details
    Acronym: CardiAMP Heart Failure Trial
    Supporter: BioCardia Inc.
    Description: This is a prospective, multi-center, randomized, sham-controlled, double-blinded IDE trial. The purpose of this study is to determine the safety and efficacy of the CardiAMP HF Cell Therapy system in patients with post-myocardial infarction (MI) heart failure. The CardiAMP Cell Therapy system is a comprehensive therapeutic treatment that comprises (i) a point-of-care cell processing platform, (ii) an intramyocardial delivery system, and a bone marrow stem cell potency assay for the treatment of ischemic heart failure. During the treatment procedure, a clinician harvests and prepares the autologous bone marrow mononuclear cells (BM MNCs) using the CardiAMP Cell Separation (CS), a point-of-care cell processing platform. The cells are then delivered via ten 0.5 ml injections using the Helix/Morph intramyocardial catheter(s). A 2016 Cochrane meta-analysis of 38 randomized controlled trials to asess the effects of BM MNCs in 1907 ischemic heart failure patients found that BM MNC treatment significantly reduced all-cause mortality, non-fatal MI, and arrhythmias although heterogeneity among the trials limited the robustness of the analysis. In addition, meta-analysis of the clinical trial evidence to date supports that intramyocardial delivery of autologous BM MNCs is safe, although more robust randomized controlled trials are required.
  • CTR-405
    Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysm (IDE Trial)
    Details
    Acronym: ALIVE (American Less Invasive Ventricular Enhancement)
    Supporter: Bioventrix Inc
    Description: Transcatheter treatment of LV aneursym via scar exclusion and reshaping of the LV. The Revivent technolgy is comprised of proprietary, permanent micro anchors delivered in a hybrid approach to the myocardium by a combined surgeon and cardiologist team under fluoroscopy and echo guidance. Eligible patients should be symptomatic and have a history of myocardial infarction resulting in anteroseptal and/or anteroapical akinesis or dyskinesis accompanied by depressed ejection fraction, poor exercise tolerance and NYHA II-III. One year endpoints to be evaluated include QOL, 6MWT, NYHA class, rehospitalization and survival. A prospective, multi-center, dual-arm pivotal study with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group. For more info, https://www.clinicaltrials.gov/ct2/show/NCT02931240?term=Revivent&rank=2
  • CTR-406
    Phase III Randomised, Double-blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure
    Details
    Acronym: EMPERIAL
    Supporter: Boehringer Ingelheim Pharmaceuticals, Inc.
    Description: EMPERIAL consists of two Phase III randomized, double-blind trials. The trials evaluate the effect of 12 weeks’ treatment of once daily empagliflozin 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction. This will be measured by the 6-minute walk test, a common measure of functional exercise capacity. • EMPERIAL-preserved [NCT03448406]: will investigate empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looks at a functional endpoint: how far patients can walk in 6 minutes and at heart failure symptoms. o Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes o Anticipated number of patients: approx. 300 o Estimated completion: 2019
  • CTR-407
    EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure
    Details
    Acronym: EMPEROR
    Supporter: Boehringer Ingelheim Pharmaceuticals, Inc.
    Description: The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) HF clinical trial program will investigate once daily empagliflozin, compared to placebo, in heart failure patients, both with and without type 2 diabetes receiving current standard of care. The program comprises the following two Phase III, randomized, double-blind trials which assess heart failure in patients with preserved ejection fraction or patients with reduced ejection fraction: • EMPEROR HF-Preserved [NCT03057951]: will investigate the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF). o Primary endpoint: time to first event of adjudicated CV (cardiovascular) death or adjudicated HHF (Hospitalization for Heart Failure) [Time Frame: up to 38 months] o Anticipated number of patients: approx. 4,100 o Estimated completion: 2020
  • CTR-408
    Multiple cArdiac seNsors for mAnaGEment of Heart Failure
    Details
    Acronym: MANAGE-HF
    Supporter: Boston Scientific Corporation
    Description: Boston Scientific has developed a high-performing heart failure composite index (HeartLogicTM) which detects the early onset of HF events from multiple sensors that target different aspects of heart failure associated with common signs and symptoms of heart failure. The MANAGE-HF trial is a multi-center, global, prospective, open label study that will investigate the clinical use of HeartLogic. MANAGE-HF will be conducted in two phases; the first phase will evaluate and optimize the clinical integration of the HeartLogic heart failure diagnostic and associated alert management process. The second phase will randomize patients to care with HeartLogic and a defined alert management process versus standard of care and will evaluate its impact on heart failure hospitalizations and death.
  • CTR-409
    Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients Clinical Study
    Details
    Acronym: SOLVE CRT
    Supporter: EBR Systems
    Description: The SOLVE CRT Study aims to evaluate the safety and efficacy of the WiSE CRT System for CRT. INTERVENTION – The WiSE CRT System uses ultrasound to Wirelessly transmit power to an electrode in a Customized LV pacing location Endocardially, accomplishing synchronous RV & LV pacing = BiV pacing for CRT. RECRUITING – CRT non-responders or, previously untreatable due to failed CS lead implantation, or CS lead programmed off or, high risk upgrades with contraindications to CS lead implant DESIGN – Multi-center, randomized, two-arm, double blinded, prospective trial with 350 Patients at up to 45 Investigational Sites in the U.S., Europe, and Australia. Study begins in 2018 and continues until FDA approval estimated in Q4 2020. Control patients cross-over after 6 month primary endpoint evaluation.
  • CTR-410
    Study of AG10 in Amyloid Cardiomyopathy
    Details
    Acronym: N/A
    Supporter: Eidos Therapeutics, Inc.
    Description: This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study is evaluating the safety, tolerability, PK and PD of AG10 compared to placebo administered on a background of stable heart failure therapy. Screening and randomization are followed by a 28-day blinded, placebo-controlled treatment period.
  • CTR-411
    Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progress
    Details
    Acronym: ANTHEM-HFrEF
    Supporter: LivaNova USA, Inc.
    Description: ANTHEM-HFrEF is a randomized controlled study to assess the safety and efficacy of autonomic regulation therapy (ART), delivered via chronic vagus nerve stimulation (VNS) in patients with symptomatic heart failure and reduced left ventricular ejection fraction. Patients will be enrolled and randomized 2:1 to receive VITARIA™ system implantation on the right cervical vagus nerve in addition to stable guideline-directed medical therapy (therapy arm), or to continue receiving stable guideline-directed medical therapy alone (control arm). Device safety will be determined by the event-free rate from all system and implantation-related serious adverse events during the 90 day period after randomization. Efficacy will be determined by time-to-first-event of cardiovascular mortality or heart failure hospitalization following randomization. Concurrently, interim analyses will be performed for symptomatic improvement. The ANTHEM-HFrEF study incorporates adaptive sample size selection, and will randomize between 400 and 1000 patients. The estimated total study duration for 1000 randomized patients is 5 years.
  • CTR-412
    Multicenter, open-label, study to evaluate the safety, tolerability, pharmacokinetics and, pharmacodynamics of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared with enalapril in pediatric patients from 1 month to
    Details
    Acronym: PANORAMA- HF
    Supporter: Novartis Pharmaceuticals Corporation
    Description: PANORAMA (LCZ696B2319) is the largest prospective pediatric Heart Failure (HF) trial conducted to date. The goal of PANORAMA is to determine if LCZ696 (sacubitril/valsartan) is superior to enalapril for treatment of pediatric HF in patients with reduced systemic left ventricular systolic function. There are two parts to the study. Part 1 will study a single dose response in a small number of pediatric heart failure patients to determine the appropriate dose for Part 2. The goal of Part 2 is to determine if LCZ696 given over 52 weeks is safe and offers a greater benefit compared to enalapril in pediatric heart failure patients.
  • CTR-413
    Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
    Details
    Acronym: SOLOIST-WHF Trial
    Supporter: Sanofi
    Description: The SOLOIST study will assess the effect of sotagliflozin on the reduction of cardiovascular mortality and morbidity (composite of cardiovascular death or hospitalization for heart failure) compared to placebo in hemodynamically stable patients with type 2 diabetes and heart failure after admission for worsening heart failure.
    The SOLOIST-WHF trial will enroll a total of 4000 patients with preserved (HFpEF) and reduced (HFrEF) ejection fraction, 18 to 85 years of age. The estimated study duration for a given patient will be approximately 3 to 32 months.
  • CTR-414
    REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
    Details
    Acronym: RELIEVE-HF
    Supporter: V-Wave, Inc.
    Description: The RELIEVE-HF study is a prospective 500 patient, international, multicenter, randomized, controlled, double-blinded clinical trial evaluating the safety and effectiveness of the V-Wave interatrial shunt device for treating highly symptomatic Heart Failure patients with NYHA Class III or ambulatory Class IV symptoms with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Approximately 50 North American sites are expected to participate with another 20 centers in the EU and Israel. Each site may implant up to 3 Roll-in patients before randomizing to become familiar with the device and procedures. Along with approximately 100 Roll-in patients, another 400 patients will be randomized, with a possible increase up to a total of 600 randomized patients based on the results of a planned interim analysis. The duration of follow-up at the primary endpoint will range from a minimum of 12 (for the last enrolled patient) to a maximum of 24 months. Patients randomized to the Control group will have the opportunity to cross-over and receive a shunt implant when they are unblinded. The shunt is implanted during a minimally invasive cardiac catheterization procedure.
NIH Clinical Trial Row
  • CTR-NIH-415
    Dilated Cardiomyopathy Consortium: DCM Discovery Study
    Details
    Acronym: DCM Discovery Study
    Supporter: The Ohio State University in pilot phase; NIH support
    Description: The DCM Discovery Study is an emerging effort to collect 10,000 DCM patients and their families to more fully understand the genetics of dilated cardiomyopathy (DCM). Based at the Ohio State University, the Discovery Study is now in pilot phase and is leveraging the infrastructure and expertise of the DCM Project (https://dcmproject.com/), the parent organization of the now funded DCM Consortium. At time of writing, the DCM Consortium has 29 major US centers participating, 25 of which are now conducting the DCM Precision Medicine Study (see companion Clinical Trial Row poster). The general hypothesis being tested in the DCM Precision Medicine Study is that most of idiopathic DCM, whether familial or non-familial, has a genetic basis. Although familial idiopathic DCM is generally assumed to follow a Mendelian monogenic model in which disease is caused by single rare familial variant, the general hypothesis for the DCM Discovery Study is that the genetic basis of DCM is more complex than the Mendelian monogenic model in a substantial proportion of families. Several key aspects have been accomplished or are under way: activation of this protocol from within a single central IRB, exploration of expanded phenotypes for preliminary data, submission of preliminary NIH grants to fund specific hypotheses, and development of a web-based, direct-to-patient consenting marketing effort with support from The DCM Foundation established in late 2017. Similar to the DCM Precision Medicine Study, we plan to seek substantial NIH support for the DCM Discovery Study. To achieve its ambitious enrollment goal, the DCM Discovery Study requests participation from all heart failure clinicians.
  • CTR-NIH-416
    Precision Medicine for Dilated Cardiomyopathy in European and African Ancestry
    Details
    Acronym: The DCM Precision Medicine Study
    Supporter: The Ohio State University: NHLBI and NHGRI
    Description: The DCM Precision Medicine Study aims to test the general hypothesis that dilated cardiomyopathy (DCM), whether familial or non-familial, has mostly a genetic basis. The study is funded by the National Heart, Lung and Blood Institute with a supplement from the National Human Genome Research Institute. The study is now underway at 25 clinical sites of the DCM Consortium, a multi-site entity organized by the study PI to conduct genetic research in DCM. The first aim of the study recruits, enrolls and gathers clinical phenotype data of 1300 probands (600 European ancestry, 600 African ancestry, 100 Hispanic ethnicity) and their willing family members. In the second aim, proband and affected family member DNAs undergo exome sequencing, and genetic data are analyzed for relevant variants (pathogenic, likely pathogenic, and variants of uncertain significance) in DCM genes. After CLIA-compliant Sanger sequencing confirmation of likely pathogenic and pathogenic variants in the proband, genetic testing results are returned to all consented subjects by study licensed genetic counselors. In Aim 3, probands are randomized 1:1 at enrollment within strata defined by site and race/ethnicity to a communication tool designed to help with family communication of DCM genetics and risk. The primary endpoint is the proportion of living first-degree relatives enrolled 1 year following proband enrollment. At the time of writing (5July2018), the study has enrolled 620 probands (40.3% African ancestry; 45.4% females) and 765 family members. To enhance its ability to meet its recruitment targets while maintaining diversity, the study has been opened to enroll probands via web, email, phone and express mail anywhere in North America. This means that all HF clinicians are now able to refer their DCM patients to the OSU site for enrollment in this ongoing active and funded study. This is a study with benefits: not only can patients contribute to understanding DCM genetics, but probands and family members of probands with likely pathogenic and pathogenic variants will also receive genetic results returned at no cost. Additional information will be available at the poster board. Please help by referring your DCM patients with family members who are motivated to participate and to find the genetic cause of their disease. Thank you very much for considering support of this important effort to understand DCM genetics. Website: www.DCMProject.com
  • CTR-NIH-417
    Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction SPIRRIT-HFpEF
    Details
    Acronym: SPIRRIT HFpEF
    Supporter: Uppsala Clinical Research Center: NIH NHLBI
    Description: Heart failure with preserved ejection fraction (HFpEF) lacks proven therapies and recent evidence from the TOPCAT trial indicates that spironolactone might be of benefit in HFpEF. Thus, we have designed a unique pragmatic clinical trial to assess whether the initiation of spironolactone plus standard care compared to standard care alone improves outcomes in patients with HFpEF. It is a 1:1 randomized, interventional, open-label treatment trial. Approximately 3200 hundred participants will be enrolled with 2550 from Sweden and 650 from the United States. Participants that meet the entry criteria will be enrolled in the trial and for the first year will be followed by the study sites. After the first year, participants in the US will be followed by the DCRI call center until the conclusion of the study. The primary endpoint is a composite of time to cardiovascular death or first heart failure hospitalization.
  • CTR-NIH-418
    COrbaNd ASsessment Of HeaRT FaIlure StAtus Study
    Details
    Acronym: CONSORTIA
    Supporter: NIH & Rethink Medical
    Description: ReThink Medical has developed a high-performing wearable device (CorBand) that can detect the parameters associated with worsening heart failure. The purpose of the current study is to develop and validate a diagnostic algorithm for heart failure worsening in ambulatory patients with heart failure.
  • CTR-NIH-419
    ToRsemide compArisoN With furoSemide FOR Management of Heart Failure
    Details
    Acronym: TRANSFORM-HF
    Supporter: NHLBI
    Description: TRANSFORM-HF is a large-scale, pragmatic, randomized, unblinded clinical effectiveness study comparing torsemide versus furosemide as treatment for heart failure. Approximately 6,000 patients hospitalized with heart failure (both preserved and reduced ejection fraction) will be enrolled in the United States. The primary objective of the TRANSFORM-HF study is to compare the treatment strategy of torsemide versus furosemide on clinical outcomes over 12 months in patients with heart failure who are hospitalized. TRANSFORM-HF is funded by the NHLBI. Enrollment started in the Summer of 2018. For further details contact Ingrid Jones (ingrid.jones@duke.edu), or visit study website at www.transformhfstudy.org ClinicalTrials.gov-dentifier: NCT03296813.
HFSA Clinical Trial Row
  • CTR-HFSA-420
    Heart Failure Society of America Research Network
    Details
    Acronym: N/A
    Supporter: Heart Failure Society of America
    Description: To improve efficiency in clinical research, the HFSA formed a multi-disciplinary task force to gain insight into the number of HFSA members actively involved in HF clinical research and to describe the challenges of conducting clinical trials in the U.S. A survey was designed to capture information about HFSA membership, credentials, practice location, type/number of trials conducted per year and annual subject enrollment, staffing, regulatory/contract issues, and use of EHR for screening. All were asked to rank 8 perceived barriers to high quality research. Over 7500 HFSA, AHA and ACC members and colleagues were queried. There were 602 surveys completed. Of these, 466 (70%) were actively engaged in HF research and 151 (23%) were interested in research. Many US sites are interested in conducting clinical research, but report being constrained by budgetary and contractual issues. The HFSA Research Network can unify interested sites and is focused on deconstructing barriers to permit high value HF research. HFSA Research Network will partner with Industry and Governmental agencies to promote high quality research in the United States.