跳至主要内容
临床试验/2023-508875-35-00
2023-508875-35-00Authorised3 期

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)

Colorado Prevention Center0 个研究点目标入组 70 人开始时间: 2025年6月20日最近更新:
相关药物

试验速览

阶段
3 期
状态
Authorised
发起方
入组人数
70
主要终点
The primary endpoint is the time to first occurrence of cardiovascular death or a heart failure event.

研究概览

简要总结

The primary objective is to evaluate the efficacy and safety of finerenone in participants with HFrEF who are intolerant of or not eligible for treatment with sMRA. The safety objective is to assess safety and tolerability of finerenone.

入排标准

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The primary endpoint is the time to first occurrence of cardiovascular death or a heart failure event.

次要结局

  • Secondary endpoints include treatment group differences in: Timing and occurrence of total (first and recurrent) events of cardiovascular (CV) death and heart failure (HF) events. Timing and occurrence of total (first and recurrent) HF events. Change in Kansas City Cardiomyopathy Questionnaire – Total Symptom Score (KCCQ-TSS) from baseline to Month 6. Time to CV death. Time to all-cause death.

研究者

发起方
Colorado Prevention Center
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Marc Bonaca

Scientific

Colorado Prevention Center

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