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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2832

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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