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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6,000
vicadrostat
empagliflozin
placebo matching vicadrostat
Diagnostic and Medical Clinic
Mobile, Alabama, United States
NOT_YET_RECRUITINGMobile Heart Specialists, PC
Mobile, Alabama, United States
RECRUITINGVelocity Clinical Research-Chula Vista
Chula Vista, California, United States
RECRUITINGUniversity of California Irvine
Orange, California, United States
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
Key secondary endpoint: Time to first event of CV death or HHF
Time frame: up to 42 months
Key secondary endpoint: Occurrence of HHFs (first and recurrent)
Time frame: up to 42 months
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
Key secondary endpoint: Time to CV death
Time frame: up to 42 months
Key secondary endpoint: Time to all-cause mortality
Time frame: up to 42 months
Time to first HHF
Time frame: up to 42 months
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
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
Absolute change from baseline in KCCQ-TSS at Week 52
Time frame: at baseline, at week 52
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
Absolute change from baseline in KCCQ-OSS at Week 52
Time frame: 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
Time frame: at baseline, at week 32
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
North America Research Institute
San Dimas, California, United States
RECRUITINGOrange County Research Center
Tustin, California, United States
RECRUITINGAmicis Research Center (ARC)
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RECRUITINGBridgeport Hospital
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NOT_YET_RECRUITINGExcel Medical Clinical Trials
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RECRUITINGBay Area Cardiology
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