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

4. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2832

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.
Placebo komparator: Control Group
Oral treatment with placebo daily
Medicin: Placebo
Oral treatment with placebo daily

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: at least 12 months
at least 12 months

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-0377

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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