A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,600
- 试验地点
- 184
- 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 with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).
详细描述
This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced 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 electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
- •Age ≥18 years or legal age of majority if >18 years in the participant's country of residence
- •Symptomatic HFrEF per protocol defined criteria
- •Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment
- •Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)
排除标准
- •Treatment with non-steroidal MRA (nsMRA)
- •Documented prior history of severe hyperkalemia in the setting of MRA use
- •eGFR < 25 mL/min/1.73m² and / or potassium > 5.0 mmol/L
- •Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned
- •Prior or planned heart transplant
- •Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure
- •Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- •Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
- •Probable alternative cause of participant's HF
- •Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers
- •Known hypersensitivity to the IP (active substance or excipients)
- •Any other condition or therapy which would make the participant unsuitable for the study
- •Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization
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
\- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Time to first occurrence of cardiovascular (CV) death or HF event.
时间窗: Ongoing, up to ~30 months
\- Time to first CV death or HF event with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.
时间窗: Ongoing, up to ~30 months
\- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
次要结局
- Timing and occurrence of total CV deaths and HF events(Ongoing, up to ~30 months)
- Timing and occurrence of total HF events(Ongoing, up to ~30 months)
- Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.(180 days)
- Time to CV death.(Ongoing, up to ~30 months)
- Time to all-cause death.(Ongoing, up to ~30 months)