Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,832
- 试验地点
- 61
研究概览
简要总结
This study is a multicenter, double-blind, randomized, placebo-controlled trial. The purpose is to evaluate whether treatment with finerenone in patients with symptomatic severe aortic stenosis undergoing TAVI, and heart failure with LVEF ≥40% is associated with a reduction in the composite endpoint of all-cause mortality or worsening of heart failure. Participants are patients with symptomatic aortic stenosis undergoing TAVI and heart failure with LVEF≥40%. Eligible patients will be randomly assigned in a 1:1 ratio to either the finerenone group or the placebo group. Patients meeting all inclusion criteria and not any exclusion criteria will be invited to participate before discharge. All enrolled patients will consecutively receive treatment, during which serum potassium and estimated glomerular filtration rate will be closely monitored. Follow-up will be conducted at 30 days, 12 months at clinic, and 3 months, 6 months, 9 months and every 6 months after 12 months of enrollment online or via telephone (at clinic if necessary). The final visit will be conducted for all enrolled patients at the end of the study.
详细描述
Inclusion criteria:
- Age ≥ 65 years.
- Patients with severe aortic stenosis (aortic valve area < 1.0 cm2 or indexed area < 0.6 cm2/m2, or mean transvalvular aortic gradient ≥ 40 mmHg or velocity of blood flow through the valve ≥ 4.0 m/s) undergoing transfemoral TAVI.
- New York Heart Association class ≥ II.
- Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
- Informed consent has been signed.
Exclusion criteria:
- Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
- Estimated glomerular filtration rate < 25 ml/min/1.73 m².
- Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
- Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
- Pregnant or breastfeeding patients.
- Life expectancy < 1 year.
- Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years.
- •Patients with severe aortic stenosis (aortic valve area < 1.0 cm2 or indexed area < 0.6 cm2/m2, or mean transvalvular aortic gradient ≥ 40 mmHg or velocity of blood flow through the valve ≥ 4.0 m/s) undergoing transfemoral TAVI.
- •New York Heart Association class ≥ II.
- •Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
- •Informed consent has been signed.
排除标准
- •Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
- •Estimated glomerular filtration rate < 25 ml/min/1.73 m².
- •Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
- •Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
- •Pregnant or breastfeeding patients.
- •Life expectancy < 1 year.
- •Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.
研究组 & 干预措施
Treatment Group
Oral treatment with finerenone daily:
- For participants with an eGFR ≤60 mL/min/1.73 m2: Starting dose is 10 mg OD and target dose 20 mg OD.
- For participants with an eGFR >60 mL/min/1.73 m2: Starting dose is 20 mg OD and target dose 40 mg OD.
干预措施: Finerenone (Drug)
Control Group
Oral treatment with placebo daily
干预措施: Placebo (Drug)