Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 Inhibitor in Patients Hospitalized With Heart Failure (CONFIRMATION-HF)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 156
- 主要终点
- Clinical benefit
研究概览
简要总结
Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.
详细描述
This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).
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
- •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
- •Current hospitalization or recently discharged with the primary diagnosis of heart failure
- •Heart failure signs and symptoms at the time of hospital admission
- •Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
- •Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
- •Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
- •Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)
排除标准
- •Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
- •Documented prior history of severe hyperkalemia in the setting of MRA use
- •Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i
- •Estimated glomerular filtration rate (eGFR) <30 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
- •Prior or planned heart transplant
- •Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
- •Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or 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)
- •Any other condition or therapy which would make the patient unsuitable for this study
研究组 & 干预措施
Usual care
Usual care management
Finerenone plus empagliflozin
干预措施: Finerenone (Drug)
Finerenone plus empagliflozin
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Clinical benefit
时间窗: 6 months
Hierarchical composite of the following: * Time to all-cause mortality * Number of total HF events * Time to first HF event * Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method
Number of serious adverse events (AEs).
时间窗: 6 months
\- Serious AEs (excluding efficacy endpoints).
Number of adverse events leading to discontinuation of study drug.
时间窗: 6 months
\- AEs leading to discontinuation of finerenone or empagliflozin.
次要结局
- Time to first death from any cause or HF event.(6 months)
- Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).(6 months)
- Number of HF events from baseline to Day 90.(90 days)