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

Résumé

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 they start on 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/empagliflozin tablets, and the other group takes placebo/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 about 6 months 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 for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

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

   Délai up to 43 months

2. Critère de jugement secondaire

   Key secondary endpoint: Time to first event of cardiovascular death or HHF

   Délai up to 43 months

3. Critère de jugement secondaire

   Key secondary endpoint: Occurrences of HHF (first and recurrent)

   Délai up to 43 months

4. Critère de jugement secondaire

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

   Délai at baseline, at week 32

5. Critère de jugement secondaire

   Key secondary endpoint: Time to cardiovascular death

   Délai up to 43 months

6. Critère de jugement secondaire

   Key secondary endpoint: Time to all-cause mortality

   Délai up to 43 months

7. Critère de jugement secondaire

   Time to first HHF

   Délai up to 43 months

8. Critère de jugement secondaire

   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

   \* 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.

   Délai from baseline, up to 43 months

9. Critère de jugement secondaire

   Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire- Clinical Summary Score (KCCQ-CSS) 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.

   Délai at baseline, at week 32

10. Critère de jugement secondaire

    Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) 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.

    Délai at baseline, at week 52

11. Critère de jugement secondaire

    Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire- Overall Summary Score (KCCQ-OSS) 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.

    Délai at baseline, at week 32

12. Critère de jugement secondaire

    Absolute change from baseline in KCCQ-OSS 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.

    Délai at baseline, at week 52

13. Critère de jugement secondaire

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

    Délai at baseline, at week 32

14. Critère de jugement secondaire

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

    Délai at baseline, at week 32

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

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