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New treatment option for Heart Failure
Official title A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
ClinicalTrials.gov ID: NCT06424288
What this study is testing
What is vicadrostat?
vicadrostat is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heart failure.
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
- This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more.
- 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 of the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per...
- Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left...
- Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular...
You likely can't join if
- Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or...
- Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or...
- 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)...
- In case of acute decompensated HF:
See the full eligibility criteria
- At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a...
- Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical...
- Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if...
- Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
- in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants...
- in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
- At least one of the following:
- Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
- Documented hospitalisation for HF within 6 months prior to Visit 1
- Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1
- in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
- for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
- Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1
- Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF...
- Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial...
- 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
- 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...
- 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)
- Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
- Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's...
- Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) 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. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic...
- Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
- Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment...
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Chula Vista, California, United States
- Orange, California, United States
- San Dimas, California, United States
- Santa Clarita, California, United States
- Tustin, California, United States
- Bridgeport, Connecticut, United States
- Boca Raton, Florida, United States
- Brandon, Florida, United States
- Clearwater, Florida, United States
- Daytona Beach, Florida, United States
- Gainesville, Florida, United States
- Hallandale, Florida, United States
- Jacksonville, Florida, United States
- Largo, Florida, United States
- Miami, Florida, United States
- Miramar Beach, Florida, United States
- Naples, Florida, United States
- Ocala, Florida, United States
- Port Charlotte, Florida, United States
+ 463 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include Mobile, Alabama, United States; Chula Vista, California, United States; Orange, California, United States; San Dimas, California, United States; Santa Clarita, California, United States; Tustin, California, United States and 477 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.