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

Phase 3

Recruiting

• Conditions: Heart Failure
• Interventions: Drug: Vicadrostat; Drug: Empagliflozin; Drug: Placebo matching vicadrostat

• Registration Number: NCT06935370
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.

In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo and empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between 1 and about 3.5 years. During this time, they can continue their regular treatment for heart failure.

Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, must go to hospital due to heart failure, or die during the study. The time until these events are observed is compared between the treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Study First Posted: 2025-04-20
• Study Start: 2025-05-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-11
• Primary Completion: 2029-02-04
• Study Completion: 2029-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vicadrostat + empagliflozin treatment group	Vicadrostat	-
vicadrostat + empagliflozin treatment group	Empagliflozin	-
Placebo to vicadrostat + empagliflozin treatment group	Empagliflozin	-
Placebo to vicadrostat + empagliflozin treatment group	Placebo matching vicadrostat	-

Primary Outcome Measures

Name	Time	Method
Time to first event of Cardiovascular (CV) death, or Hospitalisation for heart failure (HHF), or Urgent heart failure (HF) visit	up to 43 months

Secondary Outcome Measures

Name	Time	Method
Key secondary endpoint: Time to first event of cardiovascular death or hospitalisation for heart failure	up to 43 months
Key secondary endpoint: Occurrences of hospitalisation for heart failure (first and recurrent)	up to 43 months
Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 32	at baseline, at week 32	The KCCQ is a participant reported outcome. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in people with heart failure.; The symptom frequency and symptom burden domains are merged into a total symptom score (TSS).; Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Key secondary endpoint: Time to cardiovascular death	up to 43 months
Key secondary endpoint: Time to all-cause mortality	up to 43 months
Time to first hospitalisation for heart failure	up to 43 months
Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of ≥ 50% estimated glomerular filtration rate (eGFR) or onset of sustained eGFR (CKD-EPI)cr < 10 mL/min/1.73 m²	from baseline, up to 43 months	\* Chronic dialysis is defined as dialysis continuing for at least 30 days. For this composite renal endpoint the Chronic Kidney Disease Epidemiology Collaboration creatinine ((CKD-EPI)cr) equation is used.
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire- Clinical Summary Score (KCCQ-CSS) at Week 32	at baseline, at week 32	The KCCQ is a participant reported outcome. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in people with heart failure.; The Clinical Summary Score (CSS) of the KCCQ provides a measure of symptoms and physical limitations associated with heart failure.; Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 52	at baseline, at week 52	The KCCQ is a participant reported outcome. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in people with heart failure.; The symptom frequency and symptom burden domains are merged into a total symptom score (TSS).; Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire- Overall Summary Score (KCCQ-OSS) at Week 32	at baseline, at week 32	The KCCQ is a participant reported outcome. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in people with heart failure.; In the KCCQ, an overall summary score (OSS) can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains.; Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Absolute change from baseline in KCCQ-OSS at Week 52	at baseline, at week 52	The KCCQ is a participant reported outcome. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in people with heart failure.; In the KCCQ, an overall summary score (OSS) can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains.; Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥ 130 mmHg	at baseline, at week 32
Absolute change from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥ 80 mmHg	at baseline, at week 32

Trial Locations

Locations (561)

Alliance for Multispecialty Research, LLC; 🇺🇸 Mobile, Alabama, United States

Drug Research and Analysis Corporation; 🇺🇸 Montgomery, Alabama, United States

Valley Clinical Trials, Inc.; 🇺🇸 Covina, California, United States

Orange County Research Center; 🇺🇸 Lake Forest, California, United States

Amicis Research Center; 🇺🇸 Northridge, California, United States

Care Access Research; 🇺🇸 Thousand Oaks, California, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Bay Area Cardiology; 🇺🇸 Brandon, Florida, United States

Cardiology Associates Research Co.; 🇺🇸 Daytona Beach, Florida, United States

Malcom Randall VA Medical Center; 🇺🇸 Gainesville, Florida, United States

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