Taking people in SpainPhase 3

Tests vicadrostat with empagliflozin in people with heart failure

Tests vicadrostat taken with empagliflozin against placebo in adults with heart failure.

Plain-language title generated from the registry record
Registry title: A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

Key facts

Where: Badalona, Barcelona, L'hospitalet De Llobregat, Madrid, Málaga, Murcia, Sanlúcar de Barrameda, Santiago de Compostela, Valencia, and Villamartín, SpainSee the 16 sites
Phase: Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting heart failure who have symptoms and a left ventricular ejection fraction of 40% or more, plus signs of structural heart change.

Age: 18 years or older, and at least the legal age of consent where that is higher than 18.
Sex: Men and women can join. Women who can become pregnant must use highly effective birth control.
Disease stage: Chronic heart failure diagnosed at least 3 months before the first visit, NYHA class II-IV, left ventricular ejection fraction of 40% or more, with a structural heart abnormality and raised NT-proBNP.
Earlier treatment: Must be treated with standard heart failure care set by guidelines (not counting SGLT2 inhibitors and MRAs). Must not have taken an MRA or a potassium-sparing diuretic in the 14 days before the first visit.
Biomarker or test result: Raised NT-proBNP at the central laboratory; the cut-off depends on body mass index and on atrial fibrillation or flutter. One further sign is also needed, such as diuretic treatment, a recent hospital stay for heart failure, higher NT-proBNP, or UACR of 30 mg/g or more.

Main reasons for not taking part

Treatment with an MRA or a potassium-sparing diuretic such as amiloride
Heart attack, stroke, TIA or major heart surgery in the 90 days before Visit 2
Heart transplant, waiting for one, or an implanted left ventricular assist device
Heart muscle disease such as amyloidosis or hypertrophic cardiomyopathy
Severe known valve disease or acute myocarditis in the 90 days before the first visit

Read by machine on 12 November 2026.

Where in Spain

Hospital Germans Trias i PujolBadalona, SpainTaking people
Hospital Quirónsalud BarcelonaBarcelona, SpainTaking people
Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
Bellvitge University HospitalL'hospitalet De Llobregat, SpainTaking people
Hospital General Universitario Gregorio MarañónMadrid, SpainTaking people
Hospital Universitario 12 de OctubreMadrid, SpainTaking people
Hospital Universitario La PazMadrid, SpainTaking people
Hospital Universitario Ramón y CajalMadrid, SpainTaking people
Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
University Clinical Hospital Virgen De La ArrixacaMurcia, SpainTaking people
Hospital Virgen del CaminoSanlúcar de Barrameda, SpainTaking people
Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpainTaking people
Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
Hospital General Universitario de ValenciaValencia, SpainTaking people
Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
Hospital Virgen de las MontañasVillamartín, SpainTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

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Trial details

Who runs it: Boehringer Ingelheim
Trial code: NCT06424288 EU 2023-509706-30-00
Record updated: 28 October 2026
Original description: 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. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.Read full original descriptionShow less
EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%
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. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.
Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:
* Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day.
Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.
The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.
Inclusion: 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 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 the participant information; 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 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; 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; 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 with Afib or Aflutter (at Visit 1 ECG); 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 local/international guidelines and judgment of the investigator Further inclusion criteria apply.
Exclusion: 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 based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study; 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 ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2); 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 assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG); Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2; 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 1 and until Visit 2; Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD); 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 Further exclusion criteria apply; 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.
ClinicalTrials.gov NCT06424288 · EU CTIS 2023-509706-30-00