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

Phase 3

Recruiting

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

• Registration Number: NCT06424288
• Lead Sponsor: Boehringer Ingelheim

Brief 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 and empagliflozin group: participants take vicadrostat and empagliflozin as tablets once a day.

* Placebo and empagliflozin group: participants take placebo and 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-22
• Study Start: 2024-06-17
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-25
• Last Update Posted: 2025-07-28
• Primary Completion: 2028-05-22
• Study Completion: 2028-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vicadrostat + empagliflozin	vicadrostat	-
vicadrostat + empagliflozin	Empagliflozin	-
Placebo + empagliflozin	Empagliflozin	-
Placebo + empagliflozin	Placebo	-

Primary Outcome Measures

Name	Time	Method
Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit	up to 42 months

Secondary Outcome Measures

Name	Time	Method
Key secondary endpoint: Time to all-cause mortality	up to 42 months
Absolute change from baseline in KCCQ-TSS at Week 52	at baseline, at week 52
Key secondary endpoint: Time to CV death	up to 42 months
Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32	at baseline, 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.
Absolute change from baseline in KCCQ-OSS at Week 32	at baseline, 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.
Absolute change from baseline in KCCQ-OSS at Week 52	at baseline, at week 52
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
Time to first HHF	up to 42 months
Absolute chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥80 mmHg	at baseline, at week 32
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)	up to 42 months	\* chronic dialysis is defined as dialysis continuing for at least 30 days; \*\* using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation ((CKD-EPI)cr)
Key secondary endpoint: Time to first event of CV death or HHF	up to 42 months
Key secondary endpoint: Occurrence of HHFs (first and recurrent)	up to 42 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 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.

Trial Locations

Locations (587)

Pinnacle Research Group, LLC; 🇺🇸 Anniston, Alabama, United States

Diagnostic and Medical Clinic; 🇺🇸 Mobile, Alabama, United States

Mobile Heart Specialists, PC; 🇺🇸 Mobile, Alabama, United States

Velocity Clinical Research-Chula Vista-67286; 🇺🇸 Chula Vista, California, United States

University of California Irvine; 🇺🇸 Orange, California, United States

North America Research Institute; 🇺🇸 San Dimas, California, United States

Orange County Research Center; 🇺🇸 Tustin, California, United States

Amicis Research Center (ARC); 🇺🇸 Valencia, California, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Excel Medical Clinical Trials; 🇺🇸 Boca Raton, Florida, United States

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