Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure

Description

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.

Interventions

• Finerenone (Drug)
  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.
• Placebo (Drug)
  Oral treatment with placebo daily

Eligibility criteria

Conditions

Locations

• 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