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

4 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

2832

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Comparatore placebo: Control Group
Oral treatment with placebo daily
Droga: Placebo
Oral treatment with placebo daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: at least 12 months
at least 12 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Total number of worsening of heart failure.
Lasso di tempo: at least 12 months
at least 12 months
Total number of worsening of heart failure and cardiovascular mortality.
Lasso di tempo: at least 12 months
at least 12 months
Total number of worsening of heart failure and all-cause mortality.
Lasso di tempo: at least 12 months
at least 12 months
Time to cardiovascular mortality.
Lasso di tempo: at least 12 months
at least 12 months
Time to all-cause mortality.
Lasso di tempo: at least 12 months
at least 12 months
Time to first worsening of heart failure.
Lasso di tempo: at least 12 months
at least 12 months
Time to cardiovascular mortality or first worsening of heart failure.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: at least 12 months
at least 12 months
Change from baseline in KCCQ score at 30-day and 12-month follow-up.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 30-day and 12-month follow-up
30-day and 12-month follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2029

Date di iscrizione allo studio

Primo inviato

4 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-0377

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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