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

4 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

2832

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Anhui
      • Bengbu, Anhui, Chine
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
      • Hefei, Anhui, Chine
        • The First Affiliated Hospital of University of Science and Technology of China
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine
        • Peking University Third Hospital
        • Contact:
      • Beijing, Beijing Municipality, Chine
        • Chinese People's Liberation Army General Hospital
        • Contact:
      • Beijing, Beijing Municipality, Chine
        • Beijing Anzhen Hospital Affiliated to Capital Medical University
        • Contact:
      • Beijing, Beijing Municipality, Chine
        • Fuwai Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Yongjian Wu, MD
          • Numéro de téléphone: +86-106-831-4466
          • E-mail: fuwaiwyj@163.com
      • Beijing, Beijing Municipality, Chine
        • Affiliated Beijing Chaoyang Hospital of Capital Medical University
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Chine
        • The First Affiliated Hospital of Army Medical University
        • Contact:
          • Zhihui Zhang, MD
          • Numéro de téléphone: +86-13617616980
          • E-mail: xyzpj2@126.com
      • Chongqing, Chongqing Municipality, Chine
        • Army Medical Center of the People's Liberation Army
        • Contact:
          • Gengze Wu, MD
          • Numéro de téléphone: +86-13996006248
          • E-mail: wugengze@163.com
      • Chongqing, Chongqing Municipality, Chine
        • The Second Affiliated Hospital of Army Medical University
        • Contact:
          • Jun Jin, MD
          • Numéro de téléphone: +86-13272605717
          • E-mail: jjxqyy@163.com
    • Fujian
      • Fuzhou, Fujian, Chine
        • Fujian Medical University Union Hospital
        • Contact:
          • Liangwan Chen, MD
          • Numéro de téléphone: +86-13358202350
          • E-mail: ptfangjun@126.com
        • Contact:
          • Lianglong Chen, MD
        • Sous-enquêteur:
          • Jun Fang, MD
      • Fuzhou, Fujian, Chine
        • Fuzhou University Affiliated Provincial Hospital
        • Contact:
        • Contact:
          • Xinjing Chen, MD
    • Gansu
      • Lanzhou, Gansu, Chine
        • The First Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, Chine
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, Chine
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, Chine
        • Nanfang Hospital, Southern Medical University
        • Contact:
          • Jiancheng Xiu, MD
          • Numéro de téléphone: +86-13903064940
          • E-mail: xiujc@126.com
      • Guangzhou, Guangdong, Chine
        • Guangdong Provincial People's Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, Chine
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Chunguang Qiu, MD
          • Numéro de téléphone: +86-13803898806
          • E-mail: qcg123@163.com
      • Zhengzhou, Henan, Chine
        • Henan Chest Hospital
        • Contact:
      • Zhengzhou, Henan, Chine
        • Fuwai Huazhong Cardiovascular Hospital
        • Contact:
      • Zhengzhou, Henan, Chine
        • Zhengzhou No.7 People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, Chine
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Wuhan, Hubei, Chine
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Xiaoke Shang, MD
          • Numéro de téléphone: +86-18827338233
          • E-mail: 14236338@qq.com
      • Wuhan, Hubei, Chine
        • Zhongnan Hospital of Wuhan University
        • Contact:
      • Wuhan, Hubei, Chine
        • Renmin Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, Chine
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, Chine
        • Xiangya Hospital of Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, Chine
        • Nanjing First Hospital
        • Contact:
          • Junjie Zhang, MD
          • Numéro de téléphone: +86-18951670357
          • E-mail: jameszll@163.com
      • Nanjing, Jiangsu, Chine
        • Zhongda Hospital Southeast University
        • Contact:
      • Nanjing, Jiangsu, Chine
        • Nanjing Drum Tower Hospital
        • Contact:
      • Nanjing, Jiangsu, Chine
        • Jiangsu Provincial People's Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, Chine
        • The First Hospital of China Medical University
        • Contact:
          • Liang Guo, MD
          • Numéro de téléphone: +86-13654970960
          • E-mail: doctorgl@126.com
      • Shenyang, Liaoning, Chine
        • Liaoning Provincial People's Hospital
        • Contact:
      • Shenyang, Liaoning, Chine
        • People's Liberation Army Northern Theater Command General Hospital
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, Chine
        • The First Affiliated Hospital of Air Force Medical University
        • Contact:
          • Fei Li, MD
        • Contact:
      • Xi'an, Shaanxi, Chine
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, Chine
        • The Second Affiliated Hospital of Air Force Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, Chine
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, Chine
        • Shandong Provincial Qianfoshan Hospital
        • Contact:
      • Qingdao, Shandong, Chine
        • The Affiliated Hospital of Qingdao University
        • Contact:
      • Qingdao, Shandong, Chine
        • Qingdao Municipal Hospital
        • Contact:
          • Yibing Shao, MD
          • Numéro de téléphone: +86-18661675618
          • E-mail: syb2004@yeah.net
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine
        • Shanghai Chest Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, Chine
        • Shanghai East Hospital
        • Chercheur principal:
          • Ben He, MD
        • Contact:
        • Contact:
          • Bing Yang, MD
      • Shanghai, Shanghai Municipality, Chine
        • Renji Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
      • Shanghai, Shanghai Municipality, Chine
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai Municipality, Chine
        • Zhongshan hospital, Fudan university
        • Contact:
        • Contact:
          • Lai Wei, MD
      • Shanghai, Shanghai Municipality, Chine
        • The First Affiliated Hospital of Naval Medical University
        • Contact:
      • Shanghai, Shanghai Municipality, Chine
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, Chine
        • West China Hospital, Sichuan University
        • Contact:
        • Contact:
          • Jun Shi, MD
      • Chengdu, Sichuan, Chine
        • Sichuan Provincial People's Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chine
        • Tianjin Chest Hospital
        • Contact:
          • Nan Jiang, MD
          • Numéro de téléphone: +86-13821155802
          • E-mail: tjxkcs2@163.com
        • Contact:
          • Qingliang Chen, MD
      • Tianjin, Tianjin Municipality, Chine
        • Tianjin First Central Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, Chine
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
      • Ürümqi, Xinjiang, Chine
        • Xinjiang Uygur Autonomous Region People's Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, Chine
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Xianbao Liu, MD
          • Numéro de téléphone: +86-13857173887
          • E-mail: liuxb@zju.edu.cn
      • Hangzhou, Zhejiang, Chine
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contact:
        • Contact:
          • Xiaogang Guo, MD
      • Hangzhou, Zhejiang, Chine
        • The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
        • Contact:
          • Guosheng Fu, MD
          • Numéro de téléphone: +86-571-8600-6490
          • E-mail: fugslh@126.com
      • Ningbo, Zhejiang, Chine
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
          • Zhikui Chen, MD
          • Numéro de téléphone: +86-13858288161
          • E-mail: czk3231@163.com
      • Ningbo, Zhejiang, Chine
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Wenzhou, Zhejiang, Chine
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
          • Hao Zhou, MD
          • Numéro de téléphone: +86-13968801939
          • E-mail: wyzh66@126.com
      • Wenzhou, Zhejiang, Chine
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Comparateur placebo: Control Group
Oral treatment with placebo daily
Médicament: Placebo
Oral treatment with placebo daily

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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.
Délai: at least 12 months
at least 12 months

Mesures de résultats secondaires

Mesure des résultats
Délai
Total number of worsening of heart failure.
Délai: at least 12 months
at least 12 months
Total number of worsening of heart failure and cardiovascular mortality.
Délai: at least 12 months
at least 12 months
Total number of worsening of heart failure and all-cause mortality.
Délai: at least 12 months
at least 12 months
Time to cardiovascular mortality.
Délai: at least 12 months
at least 12 months
Time to all-cause mortality.
Délai: at least 12 months
at least 12 months
Time to first worsening of heart failure.
Délai: at least 12 months
at least 12 months
Time to cardiovascular mortality or first worsening of heart failure.
Délai: 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.
Délai: 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.
Délai: at least 12 months
at least 12 months
Change from baseline in KCCQ score at 30-day and 12-month follow-up.
Délai: 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.
Délai: 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.
Délai: 30-day and 12-month follow-up
30-day and 12-month follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Second Affiliated Hospital, School of Medicine, Zhejiang University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juillet 2026

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

4 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

8 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-0377

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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