Impact of Finerenone on Cardiac Remodeling and Heart Failure Progression in Patients With Heart Failure With Preserved Ejection Fraction The FIN-HF-LVS Registry
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 194
- 主要终点
- Change in left ventricular global longitudinal strain
研究概览
简要总结
This prospective randomized study aims to evaluate the efficacy of Finerenone as add-on therapy to standard of care compared to standard of care alone in preventing heart failure worsening and preserving cardiac function assessed by left ventricular strain in patients with heart failure with preserved ejection fraction.
详细描述
Overactivation of the mineralocorticoid receptor drives inflammation fibrosis and heart failure progression. Left ventricular global longitudinal strain measured by speckle tracking echocardiography is a sensitive marker for early myocardial remodeling. This is a prospective randomized parallel assignment study. Patients with HFpEF defined by HFA-PEFF score will be randomized to Finerenone plus standard of care or standard of care alone and followed for 6 months with clinical laboratory ECG and echocardiography assessment including speckle tracking at baseline and 6 months.
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
- None
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
- •Age greater than or equal to 18 years
- •Clinically evidenced heart failure with left ventricular ejection fraction greater than or equal to 50 percent
- •HFA-PEFF score greater than or equal to 5 or score 2 to 4 with functional testing confirming HFpEF
- •Sinus rhythm on resting ECG at screening
- •Written informed consent
排除标准
- •Implanted cardiac pacemaker or defibrillator with active atrial pacing
- •Estimated glomerular filtration rate less than 25 milliliters per minute per 1.73 square meters
- •Baseline serum potassium greater than 5 milliequivalents per liter
- •Known hypersensitivity to Finerenone
研究组 & 干预措施
Finerenone plus Standard of Care
Finerenone 10 mg once daily titrated to 20 mg once daily based on serum potassium and eGFR plus standard of care for HFpEF for 6 months
干预措施: Standard of care for HFpEF Description: (Other)
Finerenone plus Standard of Care
Finerenone 10 mg once daily titrated to 20 mg once daily based on serum potassium and eGFR plus standard of care for HFpEF for 6 months
干预措施: Finerenone (Drug)
Standard of Care alone
Standard of care for HFpEF according to 2022 AHA ACC HFSA guideline without Finerenone
干预措施: Standard of care for HFpEF Description: (Other)
结局指标
主要结局
Change in left ventricular global longitudinal strain
时间窗: From baseline to 6 months
Absolute change in left ventricular global longitudinal strain measured by speckle tracking echocardiography using QLAB 10.4 software from apical four-chamber views with three consecutive heart cycles greater than 61 frames per second. More negative values indicate better function
次要结局
- Change in left ventricular reservoir strain(From baseline to 6 months)
- Number of participants with heart failure hospitalization(Up to 6 months)
- Number of participants with major adverse cardiovascular events(Up to 6 months)
- Change in NT-proBNP level(From baseline to 6 months)
- Change in NYHA functional class(From baseline to 6 months)
- Number of participants with dyspnea worsening(Up to 6 months)
- Number of participants with diuretic dose escalation(Up to 6 months)
- Number of participants with hyperkalemia(Up to 6 months)
- Number of participants with acute kidney injury(Up to 6 months)
研究者
Mostafa Mohamed Khairy
Resident Physician
Assiut University