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Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure (FINE-VALUE)

4 de maio de 2026 atualizado por: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Inclusion criteria:

  1. Age ≥ 65 years.
  2. 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.
  3. New York Heart Association class ≥ II.
  4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
  5. Informed consent has been signed.

Exclusion criteria:

  1. Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
  2. Estimated glomerular filtration rate < 25 ml/min/1.73 m².
  3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
  4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
  5. Pregnant or breastfeeding patients.
  6. Life expectancy < 1 year.
  7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

Tipo de estudo

Intervencional

Inscrição (Estimado)

2832

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
    • Anhui
      • Bengbu, Anhui, China
        • The First Affiliated Hospital of Bengbu Medical University
        • Contato:
      • Hefei, Anhui, China
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contato:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Peking University Third Hospital
        • Contato:
      • Beijing, Beijing Municipality, China
        • Chinese People's Liberation Army General Hospital
        • Contato:
      • Beijing, Beijing Municipality, China
        • Beijing Anzhen Hospital Affiliated to Capital Medical University
        • Contato:
      • Beijing, Beijing Municipality, China
        • Fuwai Hospital Chinese Academy of Medical Sciences
        • Contato:
          • Yongjian Wu, MD
          • Número de telefone: +86-106-831-4466
          • E-mail: fuwaiwyj@163.com
      • Beijing, Beijing Municipality, China
        • Affiliated Beijing Chaoyang Hospital of Capital Medical University
        • Contato:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Affiliated Hospital of Army Medical University
        • Contato:
          • Zhihui Zhang, MD
          • Número de telefone: +86-13617616980
          • E-mail: xyzpj2@126.com
      • Chongqing, Chongqing Municipality, China
        • Army Medical Center of the People's Liberation Army
        • Contato:
      • Chongqing, Chongqing Municipality, China
        • The Second Affiliated Hospital of Army Medical University
        • Contato:
          • Jun Jin, MD
          • Número de telefone: +86-13272605717
          • E-mail: jjxqyy@163.com
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
        • Contato:
        • Contato:
          • Lianglong Chen, MD
        • Subinvestigador:
          • Jun Fang, MD
      • Fuzhou, Fujian, China
        • Fuzhou University Affiliated Provincial Hospital
        • Contato:
        • Contato:
          • Xinjing Chen, MD
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
        • Contato:
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contato:
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contato:
      • Guangzhou, Guangdong, China
        • Nanfang Hospital, Southern Medical University
        • Contato:
          • Jiancheng Xiu, MD
          • Número de telefone: +86-13903064940
          • E-mail: xiujc@126.com
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital
        • Contato:
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
        • Contato:
          • Chunguang Qiu, MD
          • Número de telefone: +86-13803898806
          • E-mail: qcg123@163.com
      • Zhengzhou, Henan, China
        • Henan Chest Hospital
        • Contato:
      • Zhengzhou, Henan, China
        • Fuwai Huazhong Cardiovascular Hospital
        • Contato:
      • Zhengzhou, Henan, China
        • Zhengzhou No.7 People's Hospital
        • Contato:
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contato:
      • Wuhan, Hubei, China
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contato:
          • Xiaoke Shang, MD
          • Número de telefone: +86-18827338233
          • E-mail: 14236338@qq.com
      • Wuhan, Hubei, China
        • Zhongnan Hospital of Wuhan University
        • Contato:
      • Wuhan, Hubei, China
        • Renmin Hospital of Wuhan University
        • Contato:
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
        • Contato:
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
        • Contato:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing First Hospital
        • Contato:
          • Junjie Zhang, MD
          • Número de telefone: +86-18951670357
          • E-mail: jameszll@163.com
      • Nanjing, Jiangsu, China
        • Zhongda Hospital Southeast University
        • Contato:
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital
        • Contato:
      • Nanjing, Jiangsu, China
        • Jiangsu Provincial People's Hospital
        • Contato:
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
        • Contato:
      • Shenyang, Liaoning, China
        • Liaoning Provincial People's Hospital
        • Contato:
      • Shenyang, Liaoning, China
        • People's Liberation Army Northern Theater Command General Hospital
        • Contato:
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Air Force Medical University
        • Contato:
          • Fei Li, MD
        • Contato:
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contato:
      • Xi'an, Shaanxi, China
        • The Second Affiliated Hospital of Air Force Medical University
        • Contato:
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
        • Contato:
      • Jinan, Shandong, China
        • Shandong Provincial Qianfoshan Hospital
        • Contato:
      • Qingdao, Shandong, China
        • The Affiliated Hospital of Qingdao University
        • Contato:
      • Qingdao, Shandong, China
        • Qingdao Municipal Hospital
        • Contato:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Chest Hospital
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Shanghai East Hospital
        • Investigador principal:
          • Ben He, MD
        • Contato:
        • Contato:
          • Bing Yang, MD
      • Shanghai, Shanghai Municipality, China
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Zhongshan hospital, Fudan university
        • Contato:
        • Contato:
          • Lai Wei, MD
      • Shanghai, Shanghai Municipality, China
        • The First Affiliated Hospital of Naval Medical University
        • Contato:
      • Shanghai, Shanghai Municipality, China
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contato:
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University
        • Contato:
        • Contato:
          • Jun Shi, MD
      • Chengdu, Sichuan, China
        • Sichuan Provincial People's Hospital
        • Contato:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Chest Hospital
        • Contato:
          • Nan Jiang, MD
          • Número de telefone: +86-13821155802
          • E-mail: tjxkcs2@163.com
        • Contato:
          • Qingliang Chen, MD
      • Tianjin, Tianjin Municipality, China
        • Tianjin First Central Hospital
        • Contato:
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contato:
      • Ürümqi, Xinjiang, China
        • Xinjiang Uygur Autonomous Region People's Hospital
        • Contato:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contato:
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contato:
        • Contato:
          • Xiaogang Guo, MD
      • Hangzhou, Zhejiang, China
        • The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • Contato:
          • Guosheng Fu, MD
          • Número de telefone: +86-571-8600-6490
          • E-mail: fugslh@126.com
      • Ningbo, Zhejiang, China
        • Ningbo Medical Center Lihuili Hospital
        • Contato:
          • Zhikui Chen, MD
          • Número de telefone: +86-13858288161
          • E-mail: czk3231@163.com
      • Ningbo, Zhejiang, China
        • The First Affiliated Hospital of Ningbo University
        • Contato:
      • Wenzhou, Zhejiang, China
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contato:
          • Hao Zhou, MD
          • Número de telefone: +86-13968801939
          • E-mail: wyzh66@126.com
      • Wenzhou, Zhejiang, China
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Age ≥ 65 years.
  2. 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.
  3. New York Heart Association class ≥ II.
  4. Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
  5. Informed consent has been signed.

Exclusion Criteria:

  1. Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
  2. Estimated glomerular filtration rate < 25 ml/min/1.73 m².
  3. Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
  4. Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
  5. Pregnant or breastfeeding patients.
  6. Life expectancy < 1 year.
  7. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Treatment Group

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.
Medicamento: Finerenone

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.
Comparador de Placebo: Control Group
Oral treatment with placebo daily
Medicamento: Placebo
Oral treatment with placebo daily

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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.
Prazo: at least 12 months
at least 12 months

Medidas de resultados secundários

Medida de resultado
Prazo
Total number of worsening of heart failure.
Prazo: at least 12 months
at least 12 months
Total number of worsening of heart failure and cardiovascular mortality.
Prazo: at least 12 months
at least 12 months
Total number of worsening of heart failure and all-cause mortality.
Prazo: at least 12 months
at least 12 months
Time to cardiovascular mortality.
Prazo: at least 12 months
at least 12 months
Time to all-cause mortality.
Prazo: at least 12 months
at least 12 months
Time to first worsening of heart failure.
Prazo: at least 12 months
at least 12 months
Time to cardiovascular mortality or first worsening of heart failure.
Prazo: at least 12 months
at least 12 months
Time to cardiovascular mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.
Prazo: at least 12 months
at least 12 months
Time to all-cause mortality or first worsening of heart failure in patients with chronic kidney disease or diabetes.
Prazo: at least 12 months
at least 12 months
Change from baseline in KCCQ score at 30-day and 12-month follow-up.
Prazo: 30-day and 12-month follow-up
30-day and 12-month follow-up
Improvement from baseline in NYHA classification at 30-day and 12-month follow-up.
Prazo: 30-day and 12-month follow-up
30-day and 12-month follow-up
Change from baseline in LVMI at 30-day and 12-month follow-up.
Prazo: 30-day and 12-month follow-up
30-day and 12-month follow-up

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Second Affiliated Hospital, School of Medicine, Zhejiang University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2029

Conclusão do estudo (Estimado)

31 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

4 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de maio de 2026

Primeira postagem (Real)

8 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-0377

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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