HFpEF - Heart Failure With Preserved Ejection FractionPhase 3FINE-VALUENCT07575672
Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure
A Phase 3 study testing Finerenone in people with HFpEF - Heart Failure With Preserved Ejection Fraction and TAVI(Transcatheter Aortic Valve Implantation), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 61 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction, TAVI(Transcatheter Aortic Valve Implantation), Finerenone
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,832 participants
- Where
- 61 sitesChina
- Study dates
- 9 Oct 2026to 31 Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
61 sites in 1 country. Contact the study team or a site near you to ask about taking part.
61 sites in 1 country
China61 sites, 61 recruiting
- Not yet recruiting
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Beijing, Beijing Municipality
Li Xu, MD, +86-13701057123, imxuli@hotmail.com
- Not yet recruiting
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Guangyuan Song, MD, +86-106-441-2431, songgy_anzhen@vip.163.com
- Not yet recruiting
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality
Yundai Chen, MD, +86-13311119778, cyundai@vip.163.com
- Not yet recruiting
Fuwai Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yongjian Wu, MD, +86-106-831-4466, fuwaiwyj@163.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Yida Tang, MD, +86-13701018290, tang_yida@163.com
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
Jinjun Liu, MD, +86-13955252556, liujinjun@163.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Zhenfei Fang, MD, +86-13308487909, 2805955697@qq.com
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Yongping Bai, MD, +86-13574158616, baiyongping@csu.edu.cn
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Biao Cheng, MD, +86-18981838867, chengbiao9297@sina.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Mao Chen, MD, +86-18980602046, hmaochen@vip.sina.com
Jun Shi, MD
- Not yet recruiting
Army Medical Center of the People's Liberation Army
Chongqing, Chongqing Municipality
Gengze Wu, MD, +86-13996006248, wugengze@163.com
- Not yet recruiting
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality
Zhihui Zhang, MD, +86-13617616980, xyzpj2@126.com
- Not yet recruiting
The Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality
Jun Jin, MD, +86-13272605717, jjxqyy@163.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Liangwan Chen, MD, +86-13358202350, ptfangjun@126.com
Lianglong Chen, MD
- Not yet recruiting
Fuzhou University Affiliated Provincial Hospital
Fuzhou, Fujian
Yansong Guo, MD, +86-13509384950, ysguo1234@163.com
Xinjing Chen, MD
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Jianfang Luo, MD, +86-13602833227, kuikui2011@126.com
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Jiancheng Xiu, MD, +86-13903064940, xiujc@126.com
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Yangxin Chen, MD, +86-13632406237, tjcyx1995@163.com
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Xiaodong Zhuang, MD, +86-13760755035, zhuangxd3@mail.sysu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Weidong Li, MD, +86-13957161675, liweidong@zju.edu.cn
Xiaogang Guo, MD
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Xianbao Liu, MD, +86-13857173887, liuxb@zju.edu.cn
- Not yet recruiting
The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Guosheng Fu, MD, +86-571-8600-6490, fugslh@126.com
- Not yet recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Chao Gao, MD, +86-18629551066, woshigaochao@gmail.com
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Guipeng An, MD, +86-15288872003, guipengan@hotmail.com
- Not yet recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Xiaozhou Zheng, MD, +86-18615265354, 18615265354@163.com
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Ming Bai, MD, +86-13893220909, baiming@vip.163.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Xiangqing Kong, MD, +86-13951610365, kongxq@njmu.edu.cn
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Dongjin Wang, MD, +86-19822812099, wangdongjin@163.com
- Not yet recruiting
Nanjing First Hospital
Nanjing, Jiangsu
Junjie Zhang, MD, +86-18951670357, jameszll@163.com
- Not yet recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Genshan Ma, MD, +86-13002580569, magenshan@hotmail.com
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Zhikui Chen, MD, +86-13858288161, czk3231@163.com
- Not yet recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang
Xiaomin Chen, MD, +86-13805880193, chxmin@hotmail.com
- Not yet recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
Yibing Shao, MD, +86-18661675618, syb2004@yeah.net
- Not yet recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Lei Jiang, MD, +86-18661807311, jianglei1126@sina.com
- Not yet recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Jun Pu, MD, +86-13817577592, Pujun310@hotmail.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Ruiyan Zhang, MD, +86-13601911729, zhangruiyan@263.net
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Xin Pan, MD, +86-13641937855, panxin805@163.com
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Qi Zhang, MD, +86-13817543039, zhangqnh@hotmail.com
Bing Yang, MD
- Not yet recruiting
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality
Yuan Bai, MD, +86-13391362331, 13918306511@163.com
- Not yet recruiting
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Li Zhang, MD, +86-15925689811, li.zhang.uk@gmail.com
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
Daxin Zhou, MD, +86-13801641252, zhou.daxin@zs-hospital.sh.cn
Lai Wei, MD
- Not yet recruiting
Liaoning Provincial People's Hospital
Shenyang, Liaoning
Bo Luan, MD, +86-17702485556, luanbo369@hotmail.com
- Not yet recruiting
People's Liberation Army Northern Theater Command General Hospital
Shenyang, Liaoning
Kai Xu, MD, +86-15309880917, xukai2001@sina.com
- Not yet recruiting
The First Hospital of China Medical University
Shenyang, Liaoning
Liang Guo, MD, +86-13654970960, doctorgl@126.com
- Not yet recruiting
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
Nan Jiang, MD, +86-13821155802, tjxkcs2@163.com
Qingliang Chen, MD
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
Chengzhi Lu, MD, +86-13512967656, 30817025@nankai.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Yitong Ma, MD, +86-13669939349, maxiangxjxj@163.com
- Not yet recruiting
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang
Yining Yang, MD, +86-13199860611, yangyn5126@163.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Hao Zhou, MD, +86-13968801939, wyzh66@126.com
- Not yet recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Lianping Wu, MD, +86-13906636339, 1187263152@qq.com
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
Hong Jiang, MD, +86-13908625004, hongj0505@126.com
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Hesong Zeng, MD, +86-15172893216, zenghesong@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaoke Shang, MD, +86-18827338233, 14236338@qq.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Jinping Liu, MD, +86-13986127672, liujinping@znhospital.cn
- Not yet recruiting
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi
Jian Yang, MD, +86-13892828016, 13892828016@163.com
Fei Li, MD
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Zuyi Yuan, MD, +86-18991232643, hanke630@sina.com
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi
Yan Li, MD, +86-13892890227, fireman@fmmu.edu.cn
- Not yet recruiting
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, Henan
Yiqiang Yuan, MD, +86-13838125038, yiqiangyuan@hotmail.com
- Not yet recruiting
Henan Chest Hospital
Zhengzhou, Henan
Qiong Huang, MD, +86-13783568750, huangqiong@126.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Chunguang Qiu, MD, +86-13803898806, qcg123@163.com
- Not yet recruiting
Zhengzhou No.7 People's Hospital
Zhengzhou, Henan
Shenwei Zhang, MD, +86-15890619005, zhangsw214@163.com
About this study
Official title: 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.
Read the detailed description
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
- Conditions
- HFpEF - Heart Failure With Preserved Ejection Fraction, TAVI(Transcatheter Aortic Valve Implantation), Finerenone
- Being tested
- Finerenone, Placebo
- Keywords
- HFpEF, TAVI, Finerenone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
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.
PlaceboDrug
Oral treatment with placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Drug: Finerenone |
| Control Group | Placebo comparator | Oral treatment with placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at least 12 months
Secondary outcomes (12)
Total number of worsening of heart failure.
Measured: at least 12 months
Total number of worsening of heart failure and cardiovascular mortality.
Measured: at least 12 months
Total number of worsening of heart failure and all-cause mortality.
Measured: at least 12 months
Time to cardiovascular mortality.
Measured: at least 12 months
Time to all-cause mortality.
Measured: at least 12 months
Time to first worsening of heart failure.
Measured: at least 12 months
Time to cardiovascular mortality or first worsening of heart failure.
Measured: at least 12 months
Time to cardiovascular mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.
Measured: at least 12 months
Time to all-cause mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.
Measured: at least 12 months
Change from baseline in KCCQ score at 30-day and 12-month follow-up.
Measured: 30-day and 12-month follow-up
Improvement from baseline in NYHA classification at 30-day and 12-month follow-up.
Measured: 30-day and 12-month follow-up
Change from baseline in LVMI at 30-day and 12-month follow-up.
Measured: 30-day and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start9 Oct 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575672
- Sponsor's protocol ID
- 2026-0377
- Acronym
- FINE-VALUE
- Status last verified
- Oct 2026
- First submitted
- 4 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided