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

4 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

2832

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: 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-vergelijker: Control Group
Oral treatment with placebo daily
Geneesmiddel: Placebo
Oral treatment with placebo daily

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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.
Tijdsspanne: at least 12 months
at least 12 months

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

31 december 2029

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

4 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

4 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0377

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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