Heart Failure Research Resources and Guidelines

Poster number: CTR 201
Trial Name: Sensible medical innovations lung fluid status allows reducing readmissions reate of heart failure patients
Acronym: SMILE
Sponsor: Sensible Medical Innovations (SMI)
Description: The goal of the study is to demonstrate a significant decrease in the rate of Heart Failure (HF) re-hospitalizations based on ReDS-SensiVest™ directed treatment as an adjunct to standard of care during the entire randomized follow-up period.
Contact: Ronnie Abbo, MD

Poster number: CTR 202
Trial Name: A Phase 2b, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis
Acronym: PRONTO
Sponsor: Prothena Therapeutics LTD
Description: This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.
Contact: Wendy Currlin

Poster number: CTR 203
Trial Name: A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure
Acronym: GENETIC-AF
Sponsor: ARCA biopharma
Description: GENETIC-AF is a Phase 2B/3, double-blind, comparative effectiveness study evaluating bucindolol vs. metoprolol on the time to first event of symptomatic AF/AFL in HFREF patients who are at high risk of AF/AFL recurrence. This genotype-directed study is enrolling patients with the beta-1 389 Arg/Arg adrenergic receptor (~50% of U.S. population) GENETIC-AF is currently enrolling patients in the US, Canada, and Europe for the Phase 2B stage of the trial; site identification for Phase 3 is ongoing
Contact: Christopher Dufton, PhD

Poster number: CTR 204
Trial Name: A MULTICENTER, INTERNATIONAL, PHASE 3, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF 06291826) 20 MG OR 80 MG
Acronym: ATTR-ACT
Sponsor: Pfizer
Description: A  Double-Blind, Placebo-Controlled, Randomized Study Evaluating 2 Doses of Tafamidis Meglumine (20m and 80 mg) Compared to Placebo in Subjects With TRANSTHYRETIN CARDIOMYOPATHY (TTR-CM)
Contact: Alison Flynn

Poster number: CTR 205
Trial Name: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis
Acronym: VITAL
Sponsor: Prothena Therapeutics LTD
Description: This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.
Contact: Spencer Guthrie

Poster number: CTR 206
Trial Name: RELAX-AHF-ASIA
Acronym: CRLX030A2302
Sponsor: Novartis Pharma AG
Description: Multi center, randomized, double-blind, placebo controlled phase III study to evaluate the efficacy, safety and tolerability of intravenous infusion of 30 μg/kg/day serelaxin for 48 hours when added to standard therapy in Asian acute hear failure patients.
Contact: Naoki Sato

Poster number: CTR 207
Trial Name: comParIson Of sacubitril/valsartaN versus Enalapril on Effect on ntpRo-bnp in patients stabilized from an acute Heart Failure episode
Acronym: Pioneer-HF
Sponsor: Novartis
Description: This study will assess the effect of in hospital initiation of sacubitril/valsartan tablets vs. enalapril on time averaged proportional change in NT-proBNP in patients hospitalized for acute decompensated heart failure and reduced ejection fraction. Hospitalization for ADHF identifies patients at increased risk of death and re-hospitalization following discharge.  This increased risk justifies intervention with novel treatment strategies initiated prior to discharge to improve patient outcomes
Contact: Lesley Schofield

Poster number: CTR 208
Trial Name: A study to evaluate the Corvia Medical, Inc. IASD® System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure
Acronym: REDUCE LAP-HF RANDOMIZED TRIAL I
Sponsor: Corvia Medical, Inc
Description: RCT to evaluate the peri-procedural safety and effectiveness of implanting the InterAtrial Shunt Device System II in heart failure patients with an LV ejection fraction >40% who remain symptomatic despite optimal GDMT. Clinical outcomes will also be evaluated. Forty subjects will be randomized to implant or non-implant control group; 1:1 randomization; followed for 1 year and annually for 5 years after index procedure and implant.  Controls given the option to crossover at 1 year.
Contact: Jan Komtebedde 

Poster number: CTR 209
Trial Name: Baroreflex Activation Therapy for Heart Failure
Acronym: BeAT-HF
Sponsor: CVRx
Description: The BeAT-HF Phase III Pivotal Trial is designed to demonstrate the safety of BAROSTIM THERAPY and its effectiveness on symptoms and clinical outcomes in patients suffering from heart failure with a reduced ejection fraction. 480 patients will be randomized on a 1:1 basis to either guideline-directed medical therapy (GDMT) or BAROSTIM THERAPY + GDMT. With the Expedited Access Pathway designation, the trial will follow a two-phase design in order to accelerate potential US regulatory approval.
Contact: Seth Wilks

Poster number: CTR 210
Trial Name: AdreView Myocardial Imaging for Risk Evaluation- A Multicentre Trial to Guide ICD Implantation in NYHA II&III HF Patients with 30≤LVEF≤35 (ADMIRE-ICD)
Acronym: ADMIRE-ICD
Sponsor: GE Healthcare
Description: ADMIRE-ICD an event-driven Phase IIIb, multicentre, randomised, study to demonstrate the efficacy of AdreView™ for appropriately guiding ICD implantation in NYHA II-III HF patients with 30%≤LVEF≤35%%, and for identifying patients who are at low SCD risk and would not benefit from an ICD. Primary endpoint is all-cause mortality, and secondary endpoints include CV death, hospitalization, shocks and resource utilization. 2216 patients will be randomized (1:1) in North America and Europe.
Contact: Jose Zubeldia

Poster number: CTR 214
Trial Name: EVALUATE-HF
Acronym: EVALUATE-HF
Sponsor: Novartis Pharmaceuticals Corporation
Description: A multi-center, randomized, double-blind, double-dummy, parallel group, active-controlled, forced-titration, 12-week comparison of combined angiotensin-neprilysin inhibition with sacubitril and valsartan versus enalapril on changes in central aortic stiffness in patients with heart failure and reduced ejection fraction (HFrEF).
Contact: Lesley Schofield

Poster number: CTR 215
Trial Name: ECG Belt for CRT Response
Acronym: ECG Belt
Sponsor: Medtronic
Description: Medtronic is sponsoring the ECG Belt study, a 400 patient, prospective, randomized research study. The ECG Belt system is a diagnostic tool for optimizing CRT therapy by providing real-time feedback in the form of isochronal maps of electrical activation and metrics of electrical heterogeneity for comparing the intrinsic rhythm to various pacing configurations. The primary objective is to demonstrate benefit of using the ECG Belt system on reducing LVESV from baseline to 6 months post-implant.
Contact: Katie Weiner, PhD

Poster number: CTR 216
Trial Name: Vericiguat Global Study in Subjects with  Heart Failure with Reduced Ejection Fraction
Acronym: VICTORIA
Sponsor: Bayer and Merck
Description: Vericiguat Global Study in Subjects with  Heart Failure with Reduced Ejection Fraction (VICTORIA)
Contact: Robert Mentz

Poster number: CTR 217
Trial Name: AdaptResponse trial
Acronym: AdaptResponse
Sponsor: Medtronic plc
Description: The AdaptResponse trial is designed to test the hypothesis that AdaptivCRT® (aCRT) reduces the incidence of the combined endpoint of all-cause mortality and intervention for heart failure (HF) decompensation, compared to standard cardiac resynchronization therapy (CRT), and is expected to provide evidence on the clinical utility of aCRT-enhanced CRT systems (CRT-P & CRT-D).
Contact: Sandra Jacobs

Non-Profit CTR Application Submissions                                                    

Poster number: NP-CTR-211
Trial Name: The study to evaluate challenging Responses to Therapies for decongestion in Heart FailureTrial
Acronym:  Secret of CHF
Sponsor: Cardiovascular Clinical Science Foundation
Description: The study to evaluate Challenging Responders to Therapies for decongestion in Heart Failure
Contact: Patricia Wedge

NIH CTR Application Submissions                                                      

Poster number: NIH-CTR-212
Trial Name: Remote Wireless Telemonitoring Combined with Health Coaching Strategy (Tele-HC) to Lower Readmission Rates for Patients with Acute Decompensated Heart Failure
Acronym: Tele-HC
Sponsor: NIH
Description: The Tele-HC multicenter trial will randomize 304 subjects with acute decompensated heart failure prior to hospital dismissal to either standard management including health coaching (HC) versus management facilitated by combined remote telemonitoring (TM) and HC.  The BodyGuardian platform will be deployed for those subjects randomized to TM.  Subjects randomized to TM will wear a sensor-patch for 60 days.  The primary endpoint will be readmission frequency at 60 days.
Contact: Charles J. Bruce, MD

Poster number: NIH-CTR-213
Trial Name: INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure
Acronym: INVESTED
Sponsor: NIH
Description: The INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED) study is a multi-center, randomized, active-control clinical trial of high dose influenza vaccine compared to standard dose influenza vaccine for three seasons in 9300 adult individuals with a history of myocardial infarction or heart failure who are at high risk for cardiovascular events. The primary outcome is time to first occurrence of death or cardiopulmonary hospitalization.
Contact: Orly Vardeny, PharmD, MS