EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%

Boehringer Ingelheim1176 个研究点分布在 1 个国家目标入组 6,000 人2024年6月17日

适应症Heart Failure

干预措施vicadrostat empagliflozin placebo

概览

阶段: 3 期
干预措施: vicadrostat
疾病 / 适应症: Heart Failure
发起方: Boehringer Ingelheim
入组人数: 6000
试验地点: 1176
主要终点: Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
状态: 招募中
最后更新: 17天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

注册库

clinicaltrials.gov

开始日期

2024年6月17日

结束日期

2028年5月22日

最后更新

17天前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Boehringer Ingelheim

责任方

Sponsor

入排标准

入选标准

•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
•Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
•Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
•in participants with body mass index (BMI) \<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
•in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
•in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
•At least one of the following:

排除标准

•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
•Receiving the following treatments:
•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
•In case of acute decompensated HF:
•i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)
•i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
•Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
•Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial

研究组 & 干预措施

vicadrostat/empagliflozin

干预措施: vicadrostat

vicadrostat/empagliflozin

干预措施: empagliflozin

placebo/empagliflozin

干预措施: empagliflozin

placebo/empagliflozin

干预措施: placebo

结局指标

主要结局

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

时间窗: up to 42 months

次要结局

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)
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)
Time to first HHF(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)(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)
Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32(at baseline, at week 32)
Absolute change from baseline in KCCQ-OSS at Week 32(at baseline, at week 32)
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)