2023-509706-30-00招募中3 期
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%
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,461
- 试验地点
- 161
- 主要终点
- The composite primary endpoint is the time to first event of CV death, HHF or urgent HF visit. CV death includes death of undetermined cause.
研究概览
简要总结
The primary objective is to demonstrate the superiority of the combination of vicadrostat [...] and empagliflozin [...] compared with placebo and empagliflozin [...] for the time to first CV death, HHF or urgent HF visit in participants with HF and LVEF ≥40%.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 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.
- •Chronic HF diagnosed at least 3 months before Visit 1, and in NYHA class II-IV at Visit 1, with LVEF ≥40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI, or CT). 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 (if several values are available, the most recent one should be considered).
- •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
- •If several values are available, the most recent one should be considered.
- •Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit
- •At least one of the following: a) Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1 b) Documented hospitalisation for HF within 6 months prior to Visit 1 c) Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1 a. in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL b. for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL d) UACR ≥30 mg/g, analysed at the central laboratory at Visit
- •Treated according to best possible SOC (disregarding SGLT2is and MRAs) in accordance with applicable HF local/international guidelines and judgment of the investigator.
- •Further inclusion criteria may apply in line with the Clinical Trial Protocol.
排除标准
- •Treatment with an 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
- •Further exclusion criteria may apply in line with the Clinical Trial Protocol.
- •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. a direct renin inhibitor (e.g. aliskiren) at Visit 2 b. more than one ACEI, ARB or ARNI, used simultaneously at Visit 2 c. In case of acute decompensated HF i. i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g., nesiritide, carperitide), or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device), within 24 hours prior to randomisation (Visit 2) ii. 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) d. Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2 e. Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- •MI, TIA, stroke, coronary artery bypass graft surgery/CABG, heart valve surgery/intervention or any other major surgery (major according to the investigator’s assessment) within 90 days prior to Visit 2,or scheduled for major elective surgery (e.g. hip replacement, CABG).
- •Heart transplant recipient, awaiting heart transplant, or currently implanted LVAD.
- •Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy, known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit
- •Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1and until Visit
- •Known severe valvular heart disease (obstructive or regurgitant), as per investigator’s judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study.
- •Percutaneous coronary intervention (PCI, scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2.
结局指标
主要结局
The composite primary endpoint is the time to first event of CV death, HHF or urgent HF visit. CV death includes death of undetermined cause.
The composite primary endpoint is the time to first event of CV death, HHF or urgent HF visit. CV death includes death of undetermined cause.
次要结局
- Time to first event of CV death or HHF.
- Occurrence of HHFs (first and recurrent).
- Absolute change from baseline in KCCQ-TSS at Week 32.
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (161)
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