Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure
FINE-VALUE
1 other identifier
interventional
2,832
1 country
61
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2026
Typical duration for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2026
CompletedFirst Posted
Study publicly available on registry
May 8, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
Study Completion
Last participant's last visit for all outcomes
December 31, 2029
May 8, 2026
April 1, 2026
3.5 years
May 4, 2026
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
at least 12 months
Secondary Outcomes (12)
Total number of worsening of heart failure.
at least 12 months
Total number of worsening of heart failure and cardiovascular mortality.
at least 12 months
Total number of worsening of heart failure and all-cause mortality.
at least 12 months
Time to cardiovascular mortality.
at least 12 months
Time to all-cause mortality.
at least 12 months
- +7 more secondary outcomes
Study Arms (2)
Treatment Group
EXPERIMENTALOral 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.
Control Group
PLACEBO COMPARATOROral treatment with placebo daily
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Untreated serum/plasma potassium \> 5.0 mmol/L during the screening period or randomization visit.
- Estimated glomerular filtration rate \< 25 ml/min/1.73 m².
- Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
- Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
- Pregnant or breastfeeding patients.
- Life expectancy \< 1 year.
- Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing 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
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Army Medical Center of the People's Liberation Army
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan, China
Henan Chest Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhengzhou No.7 People's Hospital
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 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
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
People's Liberation Army Northern Theater Command General Hospital
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2026
First Posted
May 8, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
May 8, 2026
Record last verified: 2026-04