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

4 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

2832

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • 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-post: 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
        • Underutredare:
          • 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-post: 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-post: 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
        • Huvudutredare:
          • 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-post: 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:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: 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-jämförare: Control Group
Oral treatment with placebo daily
Läkemedel: Placebo
Oral treatment with placebo daily

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: at least 12 months
at least 12 months

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

31 december 2029

Avslutad studie (Beräknad)

31 december 2029

Studieregistreringsdatum

Först inskickad

4 maj 2026

Först inskickad som uppfyllde QC-kriterierna

4 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-0377

Plan för individuella deltagardata (IPD)

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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