A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
ConditionHeart Failure
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoehringer Ingelheim
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
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
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
Trial design
Design model
Parallel
Treatments tested in this trial
vicadrostat
Drugvicadrostat
empagliflozin
Drugempagliflozin
placebo
Drugplacebo matching vicadrostat
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: vicadrostat/empagliflozinExperimental treatment 2 interventions
Group B: placebo/empagliflozinPlacebo comparator 2 interventions
Trial outcomes
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 monthsSecondary outcomes
1
Key secondary endpoint: Time to first event of CV death or HHF
Time frame
up to 42 months2
Key secondary endpoint: Occurrence of HHFs (first and recurrent)
Time frame
up to 42 months3
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 324
Key secondary endpoint: Time to CV death
Time frame
up to 42 monthsSponsors and contacts
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Source ClinicalTrials.gov