Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5,200
- 试验地点
- 356
- 主要终点
- Number of serious adverse events.
研究概览
简要总结
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
详细描述
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
- •Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
- •Heart failure signs and symptoms at the time of hospital admission
- •Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
- •Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF
排除标准
- •Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
- •Documented prior history of severe hyperkalemia in the setting of MRA use
- •Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73m² or potassium >5.0 mmol/L at screening
- •Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
- •Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
- •Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
- •Probable alternative cause of participant's heart failure symptoms
- •Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
- •Known hypersensitivity to the IP (active substance or excipients)
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Finerenone
干预措施: Finerenone (Drug)
结局指标
主要结局
Number of serious adverse events.
时间窗: Ongoing, up to ~30 months
Occurrence of serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.
时间窗: Ongoing, up to ~30 months
Occurrence of adverse events leading to study drug discontinuation with finerenone compared to placebo.
Composite of total HF events and cardiovascular (CV) death.
时间窗: Ongoing, up to ~30 months
Total (first and subsequent) HF hospitalizations, urgent visits for worsening HF, and CV deaths with finerenone compared to placebo.
次要结局
- Time to first occurrence of the composite of CV death or HF event.(Ongoing, up to ~30 months)
- Total HF events.(Ongoing, up to ~30 months)
- Change from baseline in the Total Symptom Score on the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) at Month 6.(6 Months)
- Time to CV death.(Ongoing, up to ~30 months)
- Time to death from any cause.(Ongoing, up to ~30 months)