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New hope for heart patients: drug may cut death risk after valve surgery

NCT ID NCT07575672

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the drug finerenone can help people with heart failure who have had a heart valve replacement (TAVI). About 2,800 older adults will be randomly assigned to receive finerenone or a placebo. The goal is to see if the drug lowers the chance of death or worsening heart failure over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,832 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis diastolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Finerenone Hfpef - heart failure with preserved ejection fraction Tavi(transcatheter aortic valve implantation)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    61 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Beijing Chaoyang Hospital of Capital Medical University

    Beijing, Beijing Municipality, China

  • Army Medical Center of the People's Liberation Army

    Chongqing, Chongqing Municipality, China

  • Beijing Anzhen Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, China

  • Chinese People's Liberation Army General Hospital

    Beijing, Beijing Municipality, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

  • Fuwai Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, China

  • Fuwai Huazhong Cardiovascular Hospital

    Zhengzhou, Henan, China

  • Fuzhou University Affiliated Provincial Hospital

    Fuzhou, Fujian, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Henan Chest Hospital

    Zhengzhou, Henan, China

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, China

  • Liaoning Provincial People's Hospital

    Shenyang, Liaoning, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • Nanjing First Hospital

    Nanjing, Jiangsu, China

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, China

  • People's Liberation Army Northern Theater Command General Hospital

    Shenyang, Liaoning, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, China

  • Qingdao Municipal Hospital

    Qingdao, Shandong, China

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, China

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Air Force Medical University

    Xi'an, Shaanxi, China

  • The First Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Naval Medical University

    Shanghai, Shanghai Municipality, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, China

  • The Second Affiliated Hospital of Air Force Medical University

    Xi'an, Shaanxi, China

  • The Second Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality, China

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, China

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, China

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, China

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang, China

  • Zhengzhou No.7 People's Hospital

    Zhengzhou, Henan, China

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, China

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