Heart Failure study: Vicadrostat vs Empagliflozin
Official title 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
ClinicalTrials.gov ID: NCT06935370
What this study is testing
What is vicadrostat?
An investigational oral tablet being studied for chronic heart failure with reduced ejection fraction.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see whether adding vicadrostat to empagliflozin improves outcomes for people with chronic heart failure and a left‑ventricle ejection fraction below 40%.
- Who it's for
- Adults who have had chronic heart failure for at least three months and whose heart’s pumping ability is less than 40%.
- What's involved
- Participants will take either vicadrostat/empagliflozin tablets or placebo/empagliflozin tablets once daily for up to 3.5 years, while continuing their usual heart‑failure treatment. They will visit the study site regularly, answer health questionnaires, and may be contacted by phone. Doctors will record any worsening heart‑failure symptoms, hospital visits, or deaths.
- Time commitment
- The study can last up to about 3.5 years, with regular site visits and phone contacts as needed, depending on how long each participant stays in the study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals...
- Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH...
- Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with...
- Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory
You likely can't join if
- Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation...
- Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or...
- 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)...
- 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
See the full eligibility criteria
- At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation...
- Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year...
- Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \< 40% per local reading...
- Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory
- Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart...
- 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 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.
- 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
- 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.
- 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...
- Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
- Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
- Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g.
- Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Covina, California, United States
- Merced, California, United States
- Newport Beach, California, United States
- San Diego, California, United States
- Thousand Oaks, California, United States
- Daytona Beach, Florida, United States
- Doral, Florida, United States
- Gainesville, Florida, United States
- Hallandale, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Palmetto Bay, Florida, United States
- Port Charlotte, Florida, United States
- Saint Augustine, Florida, United States
- Tampa, Florida, United States
- Wellington, Florida, United States
- Wesley Chapel, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
+ 391 more site(s).
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Covina, California, United States; Merced, California, United States; Newport Beach, California, United States; San Diego, California, United States; Thousand Oaks, California, United States; Daytona Beach, Florida, United States and 405 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.