A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart (NCT06935370)
🩺 Plain-English Summary (8th-Grade Level)
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (16 items).
Location: Cure Clinical Research — Beverly Hills, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria:
- Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.
- Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.
- Receiving the following treatments:
- A direct renin inhibitor (e.g. aliskiren) at Visit 2
- More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2
- Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
- In case of acute decompensated HF:
- i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation
- i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
- Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (589 Sites)
- Cure Clinical Research — Beverly Hills, California
- Valley Clinical Trials, Inc. — Covina, California
- North Coast Cardiology — Encinitas, California
- Merced Vein and Vascular Center — Merced, California
- Radin Cardiovascular Medical Group — Newport Beach, California
- Amicis Research Center - Nordhoff — Northridge, California
- University of California San Diego — San Diego, California
- Paradigm Clinical Research - San Diego — San Diego, California
- Amicis Research Corporate — Santa Clarita, California
- Care Access Research — Thousand Oaks, California
- Bay Area Cardiology — Brandon, Florida
- Cardiology Associates Research Co. — Daytona Beach, Florida
- Suncoast Research Associates, LLC — Doral, Florida
- Malcom Randall VA Medical Center — Gainesville, Florida
- Velocity Clinical Research-Hallandale Beach-67888 — Hallandale, Florida
- University of Florida — Jacksonville, Florida
- East Coast Institute For Research, LLC — Jacksonville, Florida
- Jacksonville Center for Clinical Research — Jacksonville, Florida
- University of Miami - Miller School of Medicine — Miami, Florida
- Infinite Clinical Research Inc — Miami, Florida
- Inpatient Research Clinic, LLC — Miami Lakes, Florida
- Innovation Medical Research Center — Palmetto Bay, Florida
- Peace River Cardiovascular Center — Port Charlotte, Florida
- St. Johns Center for Clinical Research — Saint Augustine, Florida
- University of South Florida — Tampa, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.