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NCT07575672RecruitingPhase 3

Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

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

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
2832 (estimated)
First submitted
4 May 2026
Start date
9 Oct 2026
Primary completion date
31 Dec 2029
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT number
NCT07575672

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 2832
  • From 9 Oct 2026 to the primary completion date, 31 Dec 2029
  • 61 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
  • Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

Other illness

  • Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.

Lab values

  • Untreated serum/plasma potassium \> 5.0 mmol/L during the screening period or randomization visit.

Other

  • Estimated glomerular filtration rate \< 25 ml/min/1.73 m².
  • Pregnant or breastfeeding patients.
  • Life expectancy \< 1 year.

Who the study is looking for

  • 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.

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Beijing Chaoyang Hospital of Capital Medical University
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BeijingChinaNot yet recruiting
Beijing Anzhen Hospital Affiliated to Capital Medical University
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BeijingChinaNot yet recruiting
Fuwai Hospital Chinese Academy of Medical Sciences
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BeijingChinaNot yet recruiting
Peking University Third Hospital
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BeijingChinaNot yet recruiting
Chinese People's Liberation Army General Hospital
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BeijingChinaNot yet recruiting
The First Affiliated Hospital of Bengbu Medical University
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BengbuChinaNot yet recruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaNot yet recruiting
Xiangya Hospital of Central South University
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ChangshaChinaNot yet recruiting
West China Hospital,Sichuan University
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ChengduChinaNot yet recruiting
Sichuan Provincial People's Hospital
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ChengduChinaNot yet recruiting
the second affiliated hospital of Army medical university
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ChongqingChinaNot yet recruiting
Army Medical Center of the People's Liberation Army
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ChongqingChinaNot yet recruiting
The First Affiliated Hospital of Army Medical University
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ChongqingChinaNot yet recruiting
Fujian Medical University Union Hospital
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FuzhouChinaNot yet recruiting
Fuzhou University Affiliated Provincial Hospital
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FuzhouChinaNot yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaNot yet recruiting
Nanfang Hospital, Southern Medical University
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GuangzhouChinaNot yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaNot yet recruiting
Guangdong Provincial People's Hospital
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GuangzhouChinaNot yet recruiting
The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
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HangzhouChinaNot yet recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaNot yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
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HangzhouChinaRecruiting
The First Affiliated Hospital of University of Science and Technology of China
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HefeiChinaNot yet recruiting
Qilu Hospital of Shandong University
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JinanChinaNot yet recruiting
Shandong Provincial Qianfoshan Hospital
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JinanChinaNot yet recruiting
The First Hospital of Lanzhou University
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LanzhouChinaNot yet recruiting
Nanjing First Hospital
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NanjingChinaNot yet recruiting
Jiangsu Provincial People's Hospital
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NanjingChinaNot yet recruiting
Zhongda Hospital Southeast University
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NanjingChinaNot yet recruiting
Nanjing Drum Tower hospital
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NanjingChinaNot yet recruiting
The First Affiliated Hospital of Ningbo University
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NingboChinaNot yet recruiting
Ningbo Medical Center Lihuili Hospital
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NingboChinaNot yet recruiting
The Affiliated Hospital of Qingdao University
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QingdaoChinaNot yet recruiting
QingDao Municipal Hospital
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QingdaoChinaNot yet recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaNot yet recruiting
Zhongshan Hospital,Fudan University
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ShanghaiChinaNot yet recruiting
The First Affiliated Hospital of Naval Medical University
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ShanghaiChinaNot yet recruiting
Shanghai East Hospital
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ShanghaiChinaNot yet recruiting
Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine
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ShanghaiChinaNot yet recruiting
Shanghai Chest Hospital
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ShanghaiChinaNot yet recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
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ShanghaiChinaNot yet recruiting
People's Liberation Army Northern Theater Command General Hospital
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ShenyangChinaNot yet recruiting
Liaoning Provincial People's Hospital
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ShenyangChinaNot yet recruiting
The First Hospital of China Medical University
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ShenyangChinaNot yet recruiting
Tianjin First Central Hospital
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TianjinChinaNot yet recruiting
Tianjin Chest Hospital
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TianjinChinaNot yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaNot yet recruiting
Xinjiang Uygur Autonomous Region People's Hospital
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ÜrümqiChinaNot yet recruiting
The Second Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaNot yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaNot yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaNot yet recruiting
Renmin Hospital of Wuhan University
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WuhanChinaNot yet recruiting
Zhongnan Hospital of Wuhan University
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WuhanChinaNot yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaNot yet recruiting
The Second Affiliated Hospital of Air Force Medical University
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Xi’anChinaNot yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaNot yet recruiting
The First Affiliated Hospital of Air Force Medical University
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Xi’anChinaNot yet recruiting
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaNot yet recruiting
Fuwai Huazhong Cardiovascular Hospital
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ZhengzhouChinaNot yet recruiting
Henan Chest Hospital
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ZhengzhouChinaNot yet recruiting
Zhengzhou No.7 People's Hospital
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ZhengzhouChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.