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

May 4, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

2832

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Placebo Comparator: Control Group
Oral treatment with placebo daily
Drug: Placebo
Oral treatment with placebo daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: at least 12 months
at least 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total number of worsening of heart failure.
Time Frame: at least 12 months
at least 12 months
Total number of worsening of heart failure and cardiovascular mortality.
Time Frame: at least 12 months
at least 12 months
Total number of worsening of heart failure and all-cause mortality.
Time Frame: at least 12 months
at least 12 months
Time to cardiovascular mortality.
Time Frame: at least 12 months
at least 12 months
Time to all-cause mortality.
Time Frame: at least 12 months
at least 12 months
Time to first worsening of heart failure.
Time Frame: at least 12 months
at least 12 months
Time to cardiovascular mortality or first worsening of heart failure.
Time Frame: 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.
Time Frame: 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.
Time Frame: at least 12 months
at least 12 months
Change from baseline in KCCQ score at 30-day and 12-month follow-up.
Time Frame: 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.
Time Frame: 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.
Time Frame: 30-day and 12-month follow-up
30-day and 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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