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Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure (FINE-VALUE)

2026年5月4日 更新者：Second Affiliated Hospital, School of Medicine, Zhejiang University

Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Inclusion criteria:

  1. Age ≥ 65 years.
  2. 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.
  3. New York Heart Association class ≥ II.
  4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
  5. Informed consent has been signed.

Exclusion criteria:

  1. Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
  2. Estimated glomerular filtration rate < 25 ml/min/1.73 m².
  3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
  4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
  5. Pregnant or breastfeeding patients.
  6. Life expectancy < 1 year.
  7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

研究类型

介入性

注册 (估计的)

2832

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Anhui
      • Bengbu、Anhui、中国
        • The First Affiliated Hospital of Bengbu Medical University
        • 接触：
      • Hefei、Anhui、中国
        • The First Affiliated Hospital of University of Science and Technology of China
        • 接触：
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • Peking University Third Hospital
        • 接触：
      • Beijing、Beijing Municipality、中国
        • Chinese People's Liberation Army General Hospital
        • 接触：
      • Beijing、Beijing Municipality、中国
        • Beijing Anzhen Hospital Affiliated to Capital Medical University
        • 接触：
      • Beijing、Beijing Municipality、中国
        • Fuwai Hospital Chinese Academy of Medical Sciences
        • 接触：
      • Beijing、Beijing Municipality、中国
        • Affiliated Beijing Chaoyang Hospital of Capital Medical University
        • 接触：
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国
        • The First Affiliated Hospital of Army Medical University
        • 接触：
          • Zhihui Zhang, MD
          • 电话号码：+86-13617616980
          • 邮箱：xyzpj2@126.com
      • Chongqing、Chongqing Municipality、中国
        • Army Medical Center of the People's Liberation Army
        • 接触：
      • Chongqing、Chongqing Municipality、中国
        • The Second Affiliated Hospital of Army Medical University
        • 接触：
    • Fujian
      • Fuzhou、Fujian、中国
        • Fujian Medical University Union Hospital
        • 接触：
        • 接触：
          • Lianglong Chen, MD
        • 副研究员：
          • Jun Fang, MD
      • Fuzhou、Fujian、中国
        • Fuzhou University Affiliated Provincial Hospital
        • 接触：
        • 接触：
          • Xinjing Chen, MD
    • Gansu
      • Lanzhou、Gansu、中国
        • The First Hospital of Lanzhou University
        • 接触：
    • Guangdong
      • Guangzhou、Guangdong、中国
        • The First Affiliated Hospital, Sun Yat-sen University
        • 接触：
      • Guangzhou、Guangdong、中国
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • 接触：
      • Guangzhou、Guangdong、中国
        • Nanfang Hospital, Southern Medical University
        • 接触：
          • Jiancheng Xiu, MD
          • 电话号码：+86-13903064940
          • 邮箱：xiujc@126.com
      • Guangzhou、Guangdong、中国
        • Guangdong Provincial People's Hospital
        • 接触：
    • Henan
      • Zhengzhou、Henan、中国
        • The First Affiliated Hospital of Zhengzhou University
        • 接触：
          • Chunguang Qiu, MD
          • 电话号码：+86-13803898806
          • 邮箱：qcg123@163.com
      • Zhengzhou、Henan、中国
        • Henan Chest Hospital
        • 接触：
      • Zhengzhou、Henan、中国
        • Fuwai Huazhong Cardiovascular Hospital
        • 接触：
      • Zhengzhou、Henan、中国
        • Zhengzhou No.7 People's Hospital
        • 接触：
    • Hubei
      • Wuhan、Hubei、中国
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 接触：
      • Wuhan、Hubei、中国
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 接触：
      • Wuhan、Hubei、中国
        • Zhongnan Hospital of Wuhan University
        • 接触：
      • Wuhan、Hubei、中国
        • Renmin Hospital of Wuhan University
        • 接触：
    • Hunan
      • Changsha、Hunan、中国
        • The Second Xiangya Hospital of Central South University
        • 接触：
      • Changsha、Hunan、中国
        • Xiangya Hospital of Central South University
        • 接触：
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • Nanjing First Hospital
        • 接触：
      • Nanjing、Jiangsu、中国
        • Zhongda Hospital Southeast University
        • 接触：
      • Nanjing、Jiangsu、中国
        • Nanjing Drum Tower Hospital
        • 接触：
      • Nanjing、Jiangsu、中国
        • Jiangsu Provincial People's Hospital
        • 接触：
    • Liaoning
      • Shenyang、Liaoning、中国
        • The First Hospital of China Medical University
        • 接触：
      • Shenyang、Liaoning、中国
        • Liaoning Provincial People's Hospital
        • 接触：
      • Shenyang、Liaoning、中国
        • People's Liberation Army Northern Theater Command General Hospital
        • 接触：
    • Shaanxi
      • Xi'an、Shaanxi、中国
        • The First Affiliated Hospital of Air Force Medical University
        • 接触：
          • Fei Li, MD
        • 接触：
      • Xi'an、Shaanxi、中国
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • 接触：
      • Xi'an、Shaanxi、中国
        • The Second Affiliated Hospital of Air Force Medical University
        • 接触：
    • Shandong
      • Jinan、Shandong、中国
        • Qilu Hospital of Shandong University
        • 接触：
      • Jinan、Shandong、中国
        • Shandong Provincial Qianfoshan Hospital
        • 接触：
      • Qingdao、Shandong、中国
        • The Affiliated Hospital of Qingdao University
        • 接触：
      • Qingdao、Shandong、中国
        • Qingdao Municipal Hospital
        • 接触：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国
        • Shanghai Chest Hospital
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Shanghai East Hospital
        • 首席研究员：
          • Ben He, MD
        • 接触：
        • 接触：
          • Bing Yang, MD
      • Shanghai、Shanghai Municipality、中国
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Zhongshan hospital, Fudan university
        • 接触：
        • 接触：
          • Lai Wei, MD
      • Shanghai、Shanghai Municipality、中国
        • The First Affiliated Hospital of Naval Medical University
        • 接触：
      • Shanghai、Shanghai Municipality、中国
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • 接触：
    • Sichuan
      • Chengdu、Sichuan、中国
        • West China Hospital, Sichuan University
        • 接触：
        • 接触：
          • Jun Shi, MD
      • Chengdu、Sichuan、中国
        • Sichuan Provincial People's Hospital
        • 接触：
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国
        • Tianjin Chest Hospital
        • 接触：
        • 接触：
          • Qingliang Chen, MD
      • Tianjin、Tianjin Municipality、中国
        • Tianjin First Central Hospital
        • 接触：
    • Xinjiang
      • Ürümqi、Xinjiang、中国
        • The First Affiliated Hospital of Xinjiang Medical University
        • 接触：
      • Ürümqi、Xinjiang、中国
        • Xinjiang Uygur Autonomous Region People's Hospital
        • 接触：
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • 接触：
      • Hangzhou、Zhejiang、中国
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • 接触：
        • 接触：
          • Xiaogang Guo, MD
      • Hangzhou、Zhejiang、中国
        • The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • 接触：
          • Guosheng Fu, MD
          • 电话号码：+86-571-8600-6490
          • 邮箱：fugslh@126.com
      • Ningbo、Zhejiang、中国
        • Ningbo Medical Center Lihuili Hospital
        • 接触：
      • Ningbo、Zhejiang、中国
        • The First Affiliated Hospital of Ningbo University
        • 接触：
      • Wenzhou、Zhejiang、中国
        • The First Affiliated Hospital of Wenzhou Medical University
        • 接触：
      • Wenzhou、Zhejiang、中国
        • The Second Affiliated Hospital of Wenzhou Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age ≥ 65 years.
  2. 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.
  3. New York Heart Association class ≥ II.
  4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
  5. Informed consent has been signed.

Exclusion Criteria:

  1. Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
  2. Estimated glomerular filtration rate < 25 ml/min/1.73 m².
  3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
  4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
  5. Pregnant or breastfeeding patients.
  6. Life expectancy < 1 year.
  7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：Finerenone

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.
安慰剂比较：Control Group
Oral treatment with placebo daily
药品：Placebo
Oral treatment with placebo daily

研究衡量的是什么？

主要结果指标

结果测量
大体时间
A composite of all-cause mortality or worsening of heart failure (hospitalization for HF or urgent HF visit), any of the first occurrence during the follow-up.
大体时间：at least 12 months
at least 12 months

次要结果测量

结果测量
大体时间
Total number of worsening of heart failure.
大体时间：at least 12 months
at least 12 months
Total number of worsening of heart failure and cardiovascular mortality.
大体时间：at least 12 months
at least 12 months
Total number of worsening of heart failure and all-cause mortality.
大体时间：at least 12 months
at least 12 months
Time to cardiovascular mortality.
大体时间：at least 12 months
at least 12 months
Time to all-cause mortality.
大体时间：at least 12 months
at least 12 months
Time to first worsening of heart failure.
大体时间：at least 12 months
at least 12 months
Time to cardiovascular mortality or first worsening of heart failure.
大体时间：at least 12 months
at least 12 months
Time to cardiovascular mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.
大体时间：at least 12 months
at least 12 months
Time to all-cause mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.
大体时间：at least 12 months
at least 12 months
Change from baseline in KCCQ score at 30-day and 12-month follow-up.
大体时间：30-day and 12-month follow-up
30-day and 12-month follow-up
Improvement from baseline in NYHA classification at 30-day and 12-month follow-up.
大体时间：30-day and 12-month follow-up
30-day and 12-month follow-up
Change from baseline in LVMI at 30-day and 12-month follow-up.
大体时间：30-day and 12-month follow-up
30-day and 12-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-0377

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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