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.
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Meeting Application Supported by Cytokinetics
Satellite Symposia (CME)
Industry Expert Theaters (Non-CME)
Contemporary Forums (Non-CME)
Clinical Trial Row
Satellite Symposia (CME)
Saturday, September 15, 2018
- Advances in Managing Patients with T2D and HF. 1 Therapy 2 Conditions?
12:15 PM – 2:15 PM CDT | Presidential A
Chair(s): Peter Liu, MD
Supported by an educational grant from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly & Company
- Overcoming Barriers in Hyperkalemia Management in Heart Failure: An Expert Summit
12:15 PM – 2:15 PM CDT | Presidential B
Chair(s): Chair(s): Javed Butler, MD, MPH, MBA, FHFSA
Supported by an educational grant from AstraZeneca Pharmaceuticals LP
- Mechanical Circulatory Devices: Contemporary Long-Term Management
7:30 PM – 9:00 PM CDT | Tennessee C
Chair(s): Chair(s): Joseph Rogers, MD
Supported by an educational grant from Abbott
Sunday, September 16, 2018
- Changing the Perspective on Cardiac Amyloidosis: From Missed and Undiagnosed, to Common and Treatable!
7:00 PM – 9:00 PM CDT | Tennessee C
Chair(s): Martha Grogan, MD; Matt Maurer, MD
Supported by educational grants from Alnylam Pharmaceuticals, Amyloidosis Research Consortium, Eidos Therapeutics, Ionis Pharmaceuticals, Pfizer, and Takeda Pharmaceutical Company
MONDAY, September 17, 2018
- The Real World of HF: From Evidence to Clinical Care
6:00 PM – 8:00 PM CDT | Presidential A
Chair(s): James Januzzi, MD
Supported by an educational grant from Novartis Pharmaceuticals Corporation
- Heart Failure and Hyperkalemia: Applying Evidence-Based Medicine for Improved Patient Outcomes
6:00 PM – 8:00 PM CDT | Presidential B
Chair(s): Ileana Piña, MD, MPH
Supported by an educational grant from Relypsa, Inc.
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 SankyoDetailsFaculty
Nassir Azimi, MD
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 CorporationDetailsFaculty
Jeffrey Testani, MD, MTR
Hamid Moradi MD, FACP, FASN
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 AmgenDetailsFaculty
Gregg C. Fonarow, MD, FHFSA
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 TherapeuticsDetailsJoin 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!
Mazen Hanna, MD
Martha Grogan, MD
Mathew Maurer, MD
New York, NY
P. James B. Dyck, MD
Monday, September 17, 2018
- hATTR Amyloidosis: A Disease State Overview & Diagnostic Challenges
10:00 AM – 10:30 AM CDT
Sponsored by Alnylam PharmaceuticalsDetailsFaculty
Dan Jacoby, MD
Yale New Haven Medical Center
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 CorporationDetailsFaculty
Richard Wright, MD, FACC
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 CytokineticsDetailsDescription: 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
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
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 AbiomedDetailsDescription: 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.
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 MedicalDetailsDescription: 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.
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 RelypsaDetailsDescription: 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 ScientificDetailsFaculty:
John P. Boehmer, MD
Professor of Medicine, Penn State College of Medicine
Heart Failure Program Director, Penn State Milton S. Hershey Medical Center
Marie Galvao, MSN, ANP-BC, CHFN
Center for Advanced Cardiac Therapy
Montefiore Medical Center
Seth J. Rials, MD, PhD
Medical Director of Arrhythmia Services, Grant Medical Center
OhioHealth Heart and Vascular Physicians
JoAnn Lindenfeld, MD
Director, Advanced Heart Failure/Cardiac Transplantation
Vanderbilt University Medical Center
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 MedtronicDetailsDescription: 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.
Marc Silver, MD, FHFSA
Jeffrey Teuteberg, MD
Nir Uriel, MD
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 DiseaseDetailsAcronym: 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 MUTATIONDetailsAcronym: 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.
A Novel Phase 2 Study of Vericiguat in Heart Failure with Preserved Ejection Fraction (VITALITY-HFpEF)DetailsAcronym: 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.
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)DetailsAcronym: 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.
Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysm (IDE Trial)DetailsAcronym: 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
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 FaiLureDetailsAcronym: 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
EMPagliflozin outcomE tRial in patients with chrOnic heaRt failureDetailsAcronym: 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
Multiple cArdiac seNsors for mAnaGEment of Heart FailureDetailsAcronym: 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.
Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in Non-Responders and Previously Untreatable Patients Clinical StudyDetailsAcronym: 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.
Study of AG10 in Amyloid CardiomyopathyDetailsAcronym: 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.
Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce ProgressDetailsAcronym: 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.
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 toDetailsAcronym: 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.
Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)DetailsAcronym: SOLOIST-WHF Trial
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.
REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart FailureDetailsAcronym: 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
Dilated Cardiomyopathy Consortium: DCM Discovery StudyDetailsAcronym: 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.
Precision Medicine for Dilated Cardiomyopathy in European and African AncestryDetailsAcronym: 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
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction SPIRRIT-HFpEFDetailsAcronym: 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.
COrbaNd ASsessment Of HeaRT FaIlure StAtus StudyDetailsAcronym: 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.
ToRsemide compArisoN With furoSemide FOR Management of Heart FailureDetailsAcronym: TRANSFORM-HF
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 (email@example.com), or visit study website at www.transformhfstudy.org ClinicalTrials.gov-dentifier: NCT03296813.
HFSA Clinical Trial Row
Heart Failure Society of America Research NetworkDetailsAcronym: 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.