BridgeMD
A study to test whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.
EU CTIS ID: 2023-509706-30-00
What this study is testing
The primary objective is to demonstrate the superiority of the combination of vicadrostat [...] and empagliflozin [...] compared with placebo and empagliflozin [...] for the time to first CV death, HHF or urgent HF visit in participants with HF and LVEF ≥40%.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 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 low failure rate of less than 1% per year when used consistently and correctly.
- Chronic HF diagnosed at least 3 months before Visit 1, and in NYHA class II-IV at Visit 1, with LVEF ≥40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI, or CT). A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2 (if several values are available, the most recent one should be considered).
- 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 performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2. If several values are available, the most recent one should be considered.
- Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1.
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 or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study
- Further exclusion criteria may apply in line with the Clinical Trial Protocol.
- 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. a direct renin inhibitor (e.g. aliskiren) at Visit 2 b. more than one ACEI, ARB or ARNI, used simultaneously at Visit 2 c. In case of acute decompensated HF i. i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g., nesiritide, carperitide), or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device), within 24 hours prior to randomisation (Visit 2) ii. 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) d. Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2 e. Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- MI, 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).
- Heart transplant recipient, awaiting heart transplant, or currently implanted LVAD.
See the full eligibility criteria
Who can join
- 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 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 low failure rate of less than 1% per year when used consistently and correctly.
- Chronic HF diagnosed at least 3 months before Visit 1, and in NYHA class II-IV at Visit 1, with LVEF ≥40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI, or CT). A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2 (if several values are available, the most recent one should be considered).
- 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 performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2. If several values are available, the most recent one should be considered.
- Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1.
- At least one of the following: a) 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 b) Documented hospitalisation for HF within 6 months prior to Visit 1 c) Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1 a. in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL b. for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL d) UACR ≥30 mg/g, analysed at the central laboratory at Visit 1.
- Treated according to best possible SOC (disregarding SGLT2is and MRAs) in accordance with applicable HF local/international guidelines and judgment of the investigator.
- Further inclusion criteria may apply in line with the Clinical Trial Protocol.
What rules you out
- 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 MRA should not be interrupted with the intention of enrolment into the study
- Further exclusion criteria may apply in line with the Clinical Trial Protocol.
- 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. a direct renin inhibitor (e.g. aliskiren) at Visit 2 b. more than one ACEI, ARB or ARNI, used simultaneously at Visit 2 c. In case of acute decompensated HF i. i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g., nesiritide, carperitide), or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device), within 24 hours prior to randomisation (Visit 2) ii. 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) d. Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2 e. Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- MI, 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).
- Heart transplant recipient, awaiting heart transplant, or currently implanted 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 cardiomyopathy, known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2.
- Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1and 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 during the study.
- Percutaneous coronary intervention (PCI, scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- Korea, Republic of
- Brazil
- United Kingdom
- Colombia
- India
- South Africa
- Turkey
- Australia
- Mexico
- Chile
- Taiwan
- Vietnam
- United States
- Japan
- China
- Serbia
- Saudi Arabia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Argentina; Korea, Republic of; Brazil; United Kingdom; Colombia and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.