ClinicalTrials.gg
Sign In
RecruitingNCT06424288Updated Oct 28, 2026

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

A Phase 3 interventional study of vicadrostat and empagliflozin in Heart Failure, sponsored by Boehringer Ingelheim. Recruiting at 671 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Updated Oct 28, 2026Site recruiting status changed22 sites added+1 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
6,712
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Heart Failure

Browse trials for

03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 6,712 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Browse Boehringer Ingelheim studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
  2. Signed and dated written in accordance with ICH-GCP and local legislation prior to admission to the trial
  3. Male or female participants. Women of (WOCBP) must be ready and able to use highly effective methods of 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
  4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in (NYHA) class II-IV at Visit 1, with (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
  5. 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

  6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:

    1. in participants with (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
    2. 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)
    3. 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)

  7. 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
  8. 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 criteria

Exclusion criteria:

  1. 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
  2. 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

  3. 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
  4. Myocardial infarction (MI), (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)
  5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
  6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
  7. 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
  8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
  9. 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
6,712 participants (estimated)

Study arms

  • Experimental
    vicadrostat/empagliflozin

    Drug: vicadrostat · Drug: empagliflozin

  • Placebo comparator
    placebo/empagliflozin

    Drug: empagliflozin · Drug: placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit

    Time frame: up to 42 months

Secondary outcomes

  1. Key secondary endpoint: Time to first event of CV death or HHF

    Time frame: up to 42 months

  2. Key secondary endpoint: Occurrence of HHFs (first and recurrent)

    Time frame: up to 42 months

  3. Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32

    The Kansas City Cardiomyopathy Questionnaire is a patient-reported outcome instrument for use in clinical investigations in heart failure. The Total Symptom Score measures the following aspects of symptom experience in two domain scores: The "Symptom Frequency Domain" assesses frequency of the following experiences: * Lower extremity swelling in the morning * Fatigue limiting patients' ability to do what they want * Dyspnea limiting patients' ability to do what they want * Dyspnea forcing patients to sleep upright/elevated The "Symptom Burden Domain" assesses bothersomeness of the following symptoms: * Fatigue * Dyspnea * Lower extremity swelling All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.

    Time frame: at baseline, at week 32

  4. Key secondary endpoint: Time to CV death

    Time frame: up to 42 months

  5. Key secondary endpoint: Time to all-cause mortality

    Time frame: up to 42 months

  6. Time to first HHF

    Time frame: up to 42 months

  7. Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of ≥50% eGFR from baseline** or onset of sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 (composite renal endpoint)

    \* chronic dialysis is defined as dialysis continuing for at least 30 days \*\* using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation ((CKD-EPI)cr)

    Time frame: up to 42 months

  8. Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32

    The KCCQ Clinical Summary Score is a composite of the Total Symptom Score and Physical Limitations Score. The "Physical Limitations Score" measures the following physical limitations: * Dressing * Showering/bathing * Walking one block on level ground * Doing yardwork, housework or carrying groceries * Climbing a flight of stairs without stopping * Hurrying or jogging as if to catch a bus All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.

    Time frame: at baseline, at week 32

  9. Absolute change from baseline in KCCQ-TSS at Week 52

    Time frame: at baseline, at week 52

  10. Absolute change from baseline in KCCQ-OSS at Week 32

    The Kansas City Cardiomyopathy Questionnaire - overall summary score (KCCQ-OSS) is a combination of the symptom \[domain\], physical limitations, social limitations, and quality of life domains. All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.

    Time frame: at baseline, at week 32

  11. Absolute change from baseline in KCCQ-OSS at Week 52

    Time frame: at baseline, at week 52

  12. Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥130 mmHg

    Time frame: at baseline, at week 32

  13. Absolute chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥80 mmHg

    Time frame: at baseline, at week 32

07

Study locations

625 of 671 sites recruiting

Showing the first 100 of 671 sites across 30 countries. Choose a country and city above to see the rest.

08

References and documents

Related links

Individual participant data

Plan to share: Yes — Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

Access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Data sharing details ↗ · www.clinicalstudies.boehringer-ingelheim.com

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for May 2028, 47 months after the start.

Of 63 industry-sponsored phase 3 interventional studies under Heart Failure, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 44. This study's planned 47 months is above that.

Counting every sponsor, half of 151 studies reached it within 39 months; a quarter within 25 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2024
First posted
May 22, 2024
StartActual
Jun 17, 2024
Primary completionEst.
May 22, 2028
CompletionEst.
May 22, 2028
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
22 sites added, 4 sites removed. 3 sites changed recruiting status (3 now recruiting)
Show 3 sites
  • Hospital Germans Trias i Pujol · Badalona, SpainNot yet recruiting→Recruiting
  • Hospital Universitari de Bellvitge · L'Hospitalet de Llobregat, SpainNot yet recruiting→Recruiting
  • University Medical Center HCMC · Ho Chi Minh City, VietnamNot yet recruiting→Recruiting
Show 22 added (8 South Korea, 3 United States, 3 Argentina, 3 Brazil, 3 Japan, 1 Bulgaria, 1 Poland)
  • Flourish Research · Winter Park, United States
  • West Houston Area Clinical Trial Consultants, LLC - Wichita · Wichita, United States
  • West Houston Area Clinical Trial Consultants, LLC - Katy · Katy, United States
  • CPSIC SRL - Cardiologia Palermo · Buenos Aires, Argentina
  • Organizacion Medica de Investigacion (OMI) · Ciudad Autonoma Buenos Aires, Argentina
  • Santa Casa de Misericordia de Porto Alegre · Porto Alegre, Brazil
  • Hospital Ana Nery · Salvador, Brazil
  • Medical center 4LIFE Ltd. · Burgas, Bulgaria
  • SeJong General Hospital · Bucheon-si, South Korea
  • Chungbuk National University Hospital · Cheongju-si, South Korea
  • Chungnam National University Hospital · Daejeon, South Korea
  • Keimyung University Dongsan Hospital · Deagu, South Korea
  • Inha University Hospital · Incheon, South Korea
  • The Catholic University of Korea, Seoul St.Mary's Hospital · Seoul, South Korea
  • Pusan National University Yangsan Hospital · Yangsan, South Korea
  • Yeungnam University Medical Center · Daegu, South Korea
  • Fundacion Scherbovsky · Mendoza, Argentina
  • Rede AME Saúde · Recife, Brazil
  • Minamino Cardiovascular Hospital · Hachioji-shi, Japan
  • The Veritas Hospital · Kawanishi-shi, Japan
  • Ikebuchi Clinic · Osaka, Japan
  • Padre Pio Regional Hospital in Przemysl · Przemyśl, Poland
Show 4 removed
  • Clinical Site Partners, LLC · Winter Park, United States
  • West Houston Area Clinical Trial Consultants, LLC · Wichita, United States
  • Private Practice Leadership, LLC · Katy, United States
  • Santa Casa de Misericórdia de Porto Alegre · Porto Alegre, Brazil
across 3 updates, Oct 1, 2026 – Oct 28, 2026
Show all 3 updates
  1. Oct 28, 2026
    6 sites added. 2 sites changed recruiting status (2 now recruiting)
    Show 2 sites
    • Hospital Universitari de Bellvitge · L'Hospitalet de Llobregat, SpainNot yet recruiting→Recruiting
    • University Medical Center HCMC · Ho Chi Minh City, VietnamNot yet recruiting→Recruiting
    Show 6 added (3 Japan, 1 Argentina, 1 Brazil, 1 Poland)
    • Fundacion Scherbovsky · Mendoza, Argentina
    • Rede AME Saúde · Recife, Brazil
    • Minamino Cardiovascular Hospital · Hachioji-shi, Japan
    • The Veritas Hospital · Kawanishi-shi, Japan
    • Ikebuchi Clinic · Osaka, Japan
    • Padre Pio Regional Hospital in Przemysl · Przemyśl, Poland
  2. Oct 14, 2026
    1 site added
    Show site
    • Yeungnam University Medical Center · Daegu, South Korea
    + 1 other change: verification date
  3. Oct 1, 2026
    15 sites added, 4 sites removed. Hospital Germans Trias i Pujol is now Recruiting
    Show 15 added (7 South Korea, 3 United States, 2 Argentina, 2 Brazil, 1 Bulgaria)
    • Flourish Research · Winter Park, United States
    • West Houston Area Clinical Trial Consultants, LLC - Wichita · Wichita, United States
    • West Houston Area Clinical Trial Consultants, LLC - Katy · Katy, United States
    • CPSIC SRL - Cardiologia Palermo · Buenos Aires, Argentina
    • Organizacion Medica de Investigacion (OMI) · Ciudad Autonoma Buenos Aires, Argentina
    • Santa Casa de Misericordia de Porto Alegre · Porto Alegre, Brazil
    • Hospital Ana Nery · Salvador, Brazil
    • Medical center 4LIFE Ltd. · Burgas, Bulgaria
    • SeJong General Hospital · Bucheon-si, South Korea
    • Chungbuk National University Hospital · Cheongju-si, South Korea
    • Chungnam National University Hospital · Daejeon, South Korea
    • Keimyung University Dongsan Hospital · Deagu, South Korea
    • Inha University Hospital · Incheon, South Korea
    • The Catholic University of Korea, Seoul St.Mary's Hospital · Seoul, South Korea
    • Pusan National University Yangsan Hospital · Yangsan, South Korea
    Show 4 removed
    • Clinical Site Partners, LLC · Winter Park, United States
    • West Houston Area Clinical Trial Consultants, LLC · Wichita, United States
    • Private Practice Leadership, LLC · Katy, United States
    • Santa Casa de Misericórdia de Porto Alegre · Porto Alegre, Brazil

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06424288
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 22, 2024
Start date
Jun 17, 2024
Primary completion
May 22, 2028 (estimated)
Completion
May 22, 2028 (estimated)
Last update
Oct 28, 2026

Study contacts

Boehringer Ingelheim
Contact
lintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Vicadrostat

Other studies in this condition

Heart Failure →

Other studies from this sponsor

Boehringer Ingelheim →

Start the discussion