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
- Diseases
- Heart failure
- 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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Beijing Chaoyang Hospital of Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Anzhen Hospital Affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Chinese People's Liberation Army General Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The First Affiliated Hospital of Bengbu Medical University Coordinator of this site? Confirm its status | Bengbu | China | Not yet recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| the second affiliated hospital of Army medical university Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| Army Medical Center of the People's Liberation Army Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| The First Affiliated Hospital of Army Medical University Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Fuzhou University Affiliated Provincial Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of University of Science and Technology of China Coordinator of this site? Confirm its status | Hefei | China | Not yet recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| Shandong Provincial Qianfoshan Hospital Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| Nanjing First Hospital Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Jiangsu Provincial People's Hospital Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| The First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Not yet recruiting |
| Ningbo Medical Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Not yet recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| The First Affiliated Hospital of Naval Medical University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Xinhua Hospital Affiliated To Shanghai Jiao tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| People's Liberation Army Northern Theater Command General Hospital Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Liaoning Provincial People's Hospital Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| The First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Tianjin First Central Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Not yet recruiting |
| Xinjiang Uygur Autonomous Region People's Hospital Coordinator of this site? Confirm its status | Ürümqi | China | Not yet recruiting |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Not yet recruiting |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| The Second Affiliated Hospital of Air Force Medical University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| The First Affiliated Hospital of Air Force Medical University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Fuwai Huazhong Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Henan Chest Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Zhengzhou No.7 People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.