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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
EU CTIS ID: 2024-519525-38-00
What this study is testing
The primary objective is to demonstrate the superiority of vicadrostat 10 mg/empagliflozin 10 mg compared with placebo and empagliflozin 10 mg for the time to first event of CV death, HHF or urgent HF visit in participants with HF and LVEF < 40% not taking MRA.
- 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 at 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 ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in Section 4.2.2.3 of the protocol
- Chronic HF diagnosed at least 3 months before Visit 1, and in NYHA classes II to 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 LVEF assessments are available, the most recent one should be considered)
- Elevated NT-proBNP at Visit 1, analysed at the central laboratory: a. ≥ 600 pg/mL (or ≥ 400 pg/mL if hospitalised for HF within the previous 12 months,) for participants without Afib or Aflutter (Visit 1 ECG2) or b. ≥ 1200 pg/mL for participants with Afib or Aflutter (Visit 1 ECG2) (irrespective of history of HHF)
- Treated according to best possible SOC (disregarding SGLT2i and MRA) in accordance with applicable HF local/international guidelines and judgement of the investigator, which should in general include (unless contraindicated or not tolerated): • An ACE inhibitor, or ARB or ARNi; and • A beta-blocker; and • If considered appropriate by the patient’s treating physician, an SGLT2i (prior SGLT2i treatment will be replaced by the study drug at randomisation)
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 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 ACEi, ARB or 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: o 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 o 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)
- 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)
- 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 LVAD
See the full eligibility criteria
Who can join
- 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 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 ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in Section 4.2.2.3 of the protocol
- Chronic HF diagnosed at least 3 months before Visit 1, and in NYHA classes II to 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 LVEF assessments are available, the most recent one should be considered)
- Elevated NT-proBNP at Visit 1, analysed at the central laboratory: a. ≥ 600 pg/mL (or ≥ 400 pg/mL if hospitalised for HF within the previous 12 months,) for participants without Afib or Aflutter (Visit 1 ECG2) or b. ≥ 1200 pg/mL for participants with Afib or Aflutter (Visit 1 ECG2) (irrespective of history of HHF)
- Treated according to best possible SOC (disregarding SGLT2i and MRA) in accordance with applicable HF local/international guidelines and judgement of the investigator, which should in general include (unless contraindicated or not tolerated): • An ACE inhibitor, or ARB or ARNi; and • A beta-blocker; and • If considered appropriate by the patient’s treating physician, an SGLT2i (prior SGLT2i treatment will be replaced by the study drug at randomisation)
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 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 ACEi, ARB or 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: o 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 o 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)
- 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)
- 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 LVAD
- Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2
- Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Vietnam
- Canada
- Japan
- Korea, Republic of
- United Kingdom
- Serbia
- Argentina
- United States
- India
- Colombia
- Turkey
- Saudi Arabia
- China
- Chile
- Brazil
- Mexico
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 Taiwan; Vietnam; Canada; Japan; Korea, Republic of; United Kingdom and 11 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.