Efficacy and Safety of Finerenone in Patients With Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)
研究概览
简要总结
Finerenone is a new selective nonsteroidal mineral corticoid receptor antagonist (MRA), nowadays it's widely used in type 2 diabetes (T2DM) patients with chronic kidney disease (CKD), the newest trial shows finerenone improve the cardiovascular outcomes among patients with T2DM and CKD especially reduce the risk of hospitalization for heart failure. In patients with diabetic nephropathy, finerenone resulted in lower risks of CKD progression and cardiovascular events. Finerenone shows great potential therapeutic effect in chronic heart failure (CHF) patients with or without T2DM and CKD compared to eplerenone, but there is still no real world study on finerenone in patients with heart failure with reduced ejection fraction (HFrEF) and it's unclear about the effect of finerenone in CHF patients without T2DM and CKD. The investigators will conduct a study to demonstrate the efficacy and safety of finerenone in HFrEF patients compared to other MRAs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 ≥ 18 years
- •New York Heart Association(NYHA) functional classification II - IV
- •LVEF measured by the echocardiogram ≤ 45%
- •eGFR>25mL/min/1.73m²
排除标准
- •LVEF measured by the echocardiogram > 45%
- •History of allergic or hypersensitivity to drugs involved in the trial.
- •Patients with a known history of cancer, angioedema, significant congenital heart disease or rheumatic heart disease.
- •Patients diagnosed with myocarditis.
- •Probable alternative diagnoses could account for the patient's HF symptoms e.g., COPD, bronchial asthma, primary pulmonary hypertension.
- •Systolic blood pressure (SBP) ≥180mmHg or diastolic blood pressure (DBP)
- •120mmHg at visit, DBP≤90mmHg or symptomatic hypotension.
- •Patients with cardiac pacemaker
- •Pregnant woman
- •eGFR≤25mL/min/1.73m² and not accept long-term hemodialysis therapy.
- •Serum potassium >5.2 mmol/l at visit
- •Fatal or uncontrollable heart arrythmia e.g., symptomatic or persistence ventricular tachycardia, ventricular rate>150 bpm in AF patients.
- •Obvious stenosis (≥50%) of bilateral renal arteries.
结局指标
主要结局
Change in serum N-terminal pro-B-type natriuretic peptide (NT-proBNP)
时间窗: before and after 6 months of medication
The change in serum NT-proBNP levels in patients was measured before medication and after 6 months of medication to determine the improvement on heart failure
次要结局
- Composite endpoint of death and heart failure rehospitalization(during the 6-month period of medication therapy)
- Change in extracellular volume (ECV)(Before and after 3 months of continuous treatment)
- Change in left ventricular ejection fraction (LVEF)(before and after 6 months of medication)
- Change in renal function level(Before and after 3 months of continuous treatment)
研究者
Dongying Zhang
Director
Chongqing Medical University