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

4. mai 2026 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Inclusion criteria:

Age ≥ 65 years.
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.
New York Heart Association class ≥ II.
Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
Informed consent has been signed.

Exclusion criteria:

Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
Estimated glomerular filtration rate < 25 ml/min/1.73 m².
Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
Pregnant or breastfeeding patients.
Life expectancy < 1 year.
Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

Studietype

Intervensjonell

Registrering (Antatt)

2832

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Jian'an Wang, MD, PhD
Telefonnummer: +86-571-8778-4808
E-post: wangjianan111@zju.edu.cn

Studiesteder

Kina
- Anhui
  - Bengbu, Anhui, Kina
    - The First Affiliated Hospital of Bengbu Medical University
    - Ta kontakt med:
      
      Jinjun Liu, MD
      
      Telefonnummer: +86-13955252556
      
      E-post: liujinjun@163.com
  - Hefei, Anhui, Kina
    - The First Affiliated Hospital of University of Science and Technology of China
    - Ta kontakt med:
      
      Chao Gao, MD
      
      Telefonnummer: +86-18629551066
      
      E-post: woshigaochao@gmail.com
- Beijing Municipality
  - Beijing, Beijing Municipality, Kina
    - Peking University Third Hospital
    - Ta kontakt med:
      
      Yida Tang, MD
      
      Telefonnummer: +86-13701018290
      
      E-post: tang_yida@163.com
  - Beijing, Beijing Municipality, Kina
    - Chinese People's Liberation Army General Hospital
    - Ta kontakt med:
      
      Yundai Chen, MD
      
      Telefonnummer: +86-13311119778
      
      E-post: cyundai@vip.163.com
  - Beijing, Beijing Municipality, Kina
    - Beijing Anzhen Hospital Affiliated to Capital Medical University
    - Ta kontakt med:
      
      Guangyuan Song, MD
      
      Telefonnummer: +86-106-441-2431
      
      E-post: songgy_anzhen@vip.163.com
  - Beijing, Beijing Municipality, Kina
    - Fuwai Hospital Chinese Academy of Medical Sciences
    - Ta kontakt med:
      
      Yongjian Wu, MD
      
      Telefonnummer: +86-106-831-4466
      
      E-post: fuwaiwyj@163.com
  - Beijing, Beijing Municipality, Kina
    - Affiliated Beijing Chaoyang Hospital of Capital Medical University
    - Ta kontakt med:
      
      Li Xu, MD
      
      Telefonnummer: +86-13701057123
      
      E-post: imxuli@hotmail.com
- Chongqing Municipality
  - Chongqing, Chongqing Municipality, Kina
    - The First Affiliated Hospital of Army Medical University
    - Ta kontakt med:
      
      Zhihui Zhang, MD
      
      Telefonnummer: +86-13617616980
      
      E-post: xyzpj2@126.com
  - Chongqing, Chongqing Municipality, Kina
    - Army Medical Center of the People's Liberation Army
    - Ta kontakt med:
      
      Gengze Wu, MD
      
      Telefonnummer: +86-13996006248
      
      E-post: wugengze@163.com
  - Chongqing, Chongqing Municipality, Kina
    - The Second Affiliated Hospital of Army Medical University
    - Ta kontakt med:
      
      Jun Jin, MD
      
      Telefonnummer: +86-13272605717
      
      E-post: jjxqyy@163.com
- Fujian
  - Fuzhou, Fujian, Kina
    - Fujian Medical University Union Hospital
    - Ta kontakt med:
      
      Liangwan Chen, MD
      
      Telefonnummer: +86-13358202350
      
      E-post: ptfangjun@126.com
    - Ta kontakt med:
      
      Lianglong Chen, MD
    - Underetterforsker:
      
      Jun Fang, MD
  - Fuzhou, Fujian, Kina
    - Fuzhou University Affiliated Provincial Hospital
    - Ta kontakt med:
      
      Yansong Guo, MD
      
      Telefonnummer: +86-13509384950
      
      E-post: ysguo1234@163.com
    - Ta kontakt med:
      
      Xinjing Chen, MD
- Gansu
  - Lanzhou, Gansu, Kina
    - The First Hospital of Lanzhou University
    - Ta kontakt med:
      
      Ming Bai, MD
      
      Telefonnummer: +86-13893220909
      
      E-post: baiming@vip.163.com
- Guangdong
  - Guangzhou, Guangdong, Kina
    - The First Affiliated Hospital, Sun Yat-sen University
    - Ta kontakt med:
      
      Xiaodong Zhuang, MD
      
      Telefonnummer: +86-13760755035
      
      E-post: zhuangxd3@mail.sysu.edu.cn
  - Guangzhou, Guangdong, Kina
    - Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    - Ta kontakt med:
      
      Yangxin Chen, MD
      
      Telefonnummer: +86-13632406237
      
      E-post: tjcyx1995@163.com
  - Guangzhou, Guangdong, Kina
    - Nanfang Hospital, Southern Medical University
    - Ta kontakt med:
      
      Jiancheng Xiu, MD
      
      Telefonnummer: +86-13903064940
      
      E-post: xiujc@126.com
  - Guangzhou, Guangdong, Kina
    - Guangdong Provincial People's Hospital
    - Ta kontakt med:
      
      Jianfang Luo, MD
      
      Telefonnummer: +86-13602833227
      
      E-post: kuikui2011@126.com
- Henan
  - Zhengzhou, Henan, Kina
    - The First Affiliated Hospital of Zhengzhou University
    - Ta kontakt med:
      
      Chunguang Qiu, MD
      
      Telefonnummer: +86-13803898806
      
      E-post: qcg123@163.com
  - Zhengzhou, Henan, Kina
    - Henan Chest Hospital
    - Ta kontakt med:
      
      Qiong Huang, MD
      
      Telefonnummer: +86-13783568750
      
      E-post: huangqiong@126.com
  - Zhengzhou, Henan, Kina
    - Fuwai Huazhong Cardiovascular Hospital
    - Ta kontakt med:
      
      Yiqiang Yuan, MD
      
      Telefonnummer: +86-13838125038
      
      E-post: yiqiangyuan@hotmail.com
  - Zhengzhou, Henan, Kina
    - Zhengzhou No.7 People's Hospital
    - Ta kontakt med:
      
      Shenwei Zhang, MD
      
      Telefonnummer: +86-15890619005
      
      E-post: zhangsw214@163.com
- Hubei
  - Wuhan, Hubei, Kina
    - Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    - Ta kontakt med:
      
      Hesong Zeng, MD
      
      Telefonnummer: +86-15172893216
      
      E-post: zenghesong@163.com
  - Wuhan, Hubei, Kina
    - Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    - Ta kontakt med:
      
      Xiaoke Shang, MD
      
      Telefonnummer: +86-18827338233
      
      E-post: 14236338@qq.com
  - Wuhan, Hubei, Kina
    - Zhongnan Hospital of Wuhan University
    - Ta kontakt med:
      
      Jinping Liu, MD
      
      Telefonnummer: +86-13986127672
      
      E-post: liujinping@znhospital.cn
  - Wuhan, Hubei, Kina
    - Renmin Hospital of Wuhan University
    - Ta kontakt med:
      
      Hong Jiang, MD
      
      Telefonnummer: +86-13908625004
      
      E-post: hongj0505@126.com
- Hunan
  - Changsha, Hunan, Kina
    - The Second Xiangya Hospital of Central South University
    - Ta kontakt med:
      
      Zhenfei Fang, MD
      
      Telefonnummer: +86-13308487909
      
      E-post: 2805955697@qq.com
  - Changsha, Hunan, Kina
    - Xiangya Hospital of Central South University
    - Ta kontakt med:
      
      Yongping Bai, MD
      
      Telefonnummer: +86-13574158616
      
      E-post: baiyongping@csu.edu.cn
- Jiangsu
  - Nanjing, Jiangsu, Kina
    - Nanjing First Hospital
    - Ta kontakt med:
      
      Junjie Zhang, MD
      
      Telefonnummer: +86-18951670357
      
      E-post: jameszll@163.com
  - Nanjing, Jiangsu, Kina
    - Zhongda Hospital Southeast University
    - Ta kontakt med:
      
      Genshan Ma, MD
      
      Telefonnummer: +86-13002580569
      
      E-post: magenshan@hotmail.com
  - Nanjing, Jiangsu, Kina
    - Nanjing Drum Tower Hospital
    - Ta kontakt med:
      
      Dongjin Wang, MD
      
      Telefonnummer: +86-19822812099
      
      E-post: wangdongjin@163.com
  - Nanjing, Jiangsu, Kina
    - Jiangsu Provincial People's Hospital
    - Ta kontakt med:
      
      Xiangqing Kong, MD
      
      Telefonnummer: +86-13951610365
      
      E-post: kongxq@njmu.edu.cn
- Liaoning
  - Shenyang, Liaoning, Kina
    - The First Hospital of China Medical University
    - Ta kontakt med:
      
      Liang Guo, MD
      
      Telefonnummer: +86-13654970960
      
      E-post: doctorgl@126.com
  - Shenyang, Liaoning, Kina
    - Liaoning Provincial People's Hospital
    - Ta kontakt med:
      
      Bo Luan, MD
      
      Telefonnummer: +86-17702485556
      
      E-post: luanbo369@hotmail.com
  - Shenyang, Liaoning, Kina
    - People's Liberation Army Northern Theater Command General Hospital
    - Ta kontakt med:
      
      Kai Xu, MD
      
      Telefonnummer: +86-15309880917
      
      E-post: xukai2001@sina.com
- Shaanxi
  - Xi'an, Shaanxi, Kina
    - The First Affiliated Hospital of Air Force Medical University
    - Ta kontakt med:
      
      Fei Li, MD
    - Ta kontakt med:
      
      Jian Yang, MD
      
      Telefonnummer: +86-13892828016
      
      E-post: 13892828016@163.com
  - Xi'an, Shaanxi, Kina
    - The First Affiliated Hospital of Xi'an Jiaotong University
    - Ta kontakt med:
      
      Zuyi Yuan, MD
      
      Telefonnummer: +86-18991232643
      
      E-post: hanke630@sina.com
  - Xi'an, Shaanxi, Kina
    - The Second Affiliated Hospital of Air Force Medical University
    - Ta kontakt med:
      
      Yan Li, MD
      
      Telefonnummer: +86-13892890227
      
      E-post: fireman@fmmu.edu.cn
- Shandong
  - Jinan, Shandong, Kina
    - Qilu Hospital of Shandong University
    - Ta kontakt med:
      
      Guipeng An, MD
      
      Telefonnummer: +86-15288872003
      
      E-post: guipengan@hotmail.com
  - Jinan, Shandong, Kina
    - Shandong Provincial Qianfoshan Hospital
    - Ta kontakt med:
      
      Xiaozhou Zheng, MD
      
      Telefonnummer: +86-18615265354
      
      E-post: 18615265354@163.com
  - Qingdao, Shandong, Kina
    - The Affiliated Hospital of Qingdao University
    - Ta kontakt med:
      
      Lei Jiang, MD
      
      Telefonnummer: +86-18661807311
      
      E-post: jianglei1126@sina.com
  - Qingdao, Shandong, Kina
    - Qingdao Municipal Hospital
    - Ta kontakt med:
      
      Yibing Shao, MD
      
      Telefonnummer: +86-18661675618
      
      E-post: syb2004@yeah.net
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Kina
    - Shanghai Chest Hospital
    - Ta kontakt med:
      
      Xin Pan, MD
      
      Telefonnummer: +86-13641937855
      
      E-post: panxin805@163.com
  - Shanghai, Shanghai Municipality, Kina
    - Shanghai East Hospital
    - Hovedetterforsker:
      
      Ben He, MD
    - Ta kontakt med:
      
      Qi Zhang, MD
      
      Telefonnummer: +86-13817543039
      
      E-post: zhangqnh@hotmail.com
    - Ta kontakt med:
      
      Bing Yang, MD
  - Shanghai, Shanghai Municipality, Kina
    - Renji Hospital, Shanghai Jiaotong University School of Medicine
    - Ta kontakt med:
      
      Jun Pu, MD
      
      Telefonnummer: +86-13817577592
      
      E-post: Pujun310@hotmail.com
  - Shanghai, Shanghai Municipality, Kina
    - Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    - Ta kontakt med:
      
      Li Zhang, MD
      
      Telefonnummer: +86-15925689811
      
      E-post: li.zhang.uk@gmail.com
  - Shanghai, Shanghai Municipality, Kina
    - Zhongshan hospital, Fudan university
    - Ta kontakt med:
      
      Daxin Zhou, MD
      
      Telefonnummer: +86-13801641252
      
      E-post: zhou.daxin@zs-hospital.sh.cn
    - Ta kontakt med:
      
      Lai Wei, MD
  - Shanghai, Shanghai Municipality, Kina
    - The First Affiliated Hospital of Naval Medical University
    - Ta kontakt med:
      
      Yuan Bai, MD
      
      Telefonnummer: +86-13391362331
      
      E-post: 13918306511@163.com
  - Shanghai, Shanghai Municipality, Kina
    - Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    - Ta kontakt med:
      
      Ruiyan Zhang, MD
      
      Telefonnummer: +86-13601911729
      
      E-post: zhangruiyan@263.net
- Sichuan
  - Chengdu, Sichuan, Kina
    - West China Hospital, Sichuan University
    - Ta kontakt med:
      
      Mao Chen, MD
      
      Telefonnummer: +86-18980602046
      
      E-post: hmaochen@vip.sina.com
    - Ta kontakt med:
      
      Jun Shi, MD
  - Chengdu, Sichuan, Kina
    - Sichuan Provincial People's Hospital
    - Ta kontakt med:
      
      Biao Cheng, MD
      
      Telefonnummer: +86-18981838867
      
      E-post: chengbiao9297@sina.com
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, Kina
    - Tianjin Chest Hospital
    - Ta kontakt med:
      
      Nan Jiang, MD
      
      Telefonnummer: +86-13821155802
      
      E-post: tjxkcs2@163.com
    - Ta kontakt med:
      
      Qingliang Chen, MD
  - Tianjin, Tianjin Municipality, Kina
    - Tianjin First Central Hospital
    - Ta kontakt med:
      
      Chengzhi Lu, MD
      
      Telefonnummer: +86-13512967656
      
      E-post: 30817025@nankai.edu.cn
- Xinjiang
  - Ürümqi, Xinjiang, Kina
    - The First Affiliated Hospital of Xinjiang Medical University
    - Ta kontakt med:
      
      Yitong Ma, MD
      
      Telefonnummer: +86-13669939349
      
      E-post: maxiangxjxj@163.com
  - Ürümqi, Xinjiang, Kina
    - Xinjiang Uygur Autonomous Region People's Hospital
    - Ta kontakt med:
      
      Yining Yang, MD
      
      Telefonnummer: +86-13199860611
      
      E-post: yangyn5126@163.com
- Zhejiang
  - Hangzhou, Zhejiang, Kina
    - The Second Affiliated Hospital of Zhejiang University School of Medicine
    - Ta kontakt med:
      
      Xianbao Liu, MD
      
      Telefonnummer: +86-13857173887
      
      E-post: liuxb@zju.edu.cn
  - Hangzhou, Zhejiang, Kina
    - The First Affiliated Hospital of Zhejiang University school of medicine
    - Ta kontakt med:
      
      Weidong Li, MD
      
      Telefonnummer: +86-13957161675
      
      E-post: liweidong@zju.edu.cn
    - Ta kontakt med:
      
      Xiaogang Guo, MD
  - Hangzhou, Zhejiang, Kina
    - The Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
    - Ta kontakt med:
      
      Guosheng Fu, MD
      
      Telefonnummer: +86-571-8600-6490
      
      E-post: fugslh@126.com
  - Ningbo, Zhejiang, Kina
    - Ningbo Medical Center Lihuili Hospital
    - Ta kontakt med:
      
      Zhikui Chen, MD
      
      Telefonnummer: +86-13858288161
      
      E-post: czk3231@163.com
  - Ningbo, Zhejiang, Kina
    - The First Affiliated Hospital of Ningbo University
    - Ta kontakt med:
      
      Xiaomin Chen, MD
      
      Telefonnummer: +86-13805880193
      
      E-post: chxmin@hotmail.com
  - Wenzhou, Zhejiang, Kina
    - The First Affiliated Hospital of Wenzhou Medical University
    - Ta kontakt med:
      
      Hao Zhou, MD
      
      Telefonnummer: +86-13968801939
      
      E-post: wyzh66@126.com
  - Wenzhou, Zhejiang, Kina
    - The Second Affiliated Hospital of Wenzhou Medical University
    - Ta kontakt med:
      
      Lianping Wu, MD
      
      Telefonnummer: +86-13906636339
      
      E-post: 1187263152@qq.com

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

Age ≥ 65 years.
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.
New York Heart Association class ≥ II.
Left ventricular ejection fraction ≥ 40% at baseline prior TAVI.
Informed consent has been signed.

Exclusion Criteria:

Untreated serum/plasma potassium > 5.0 mmol/L during the screening period or randomization visit.
Estimated glomerular filtration rate < 25 ml/min/1.73 m².
Occurred or planned to undergo: acute myocardial infarction, cardiac resynchronization therapy device implantation, stroke, or transient ischemic attack within 30 days prior to randomization.
Known allergy, intolerance, or contraindication to mineralocorticoid receptor antagonists.
Pregnant or breastfeeding patients.
Life expectancy < 1 year.
Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Dobbelt

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: 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.	Legemiddel: 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	Legemiddel: Placebo Oral treatment with placebo daily

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

31. desember 2029

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

8. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Finerenone

Andre studie-ID-numre

2026-0377

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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

Finerenone in Patients Undergoing Transcatheter Aortic Valve Implantation With Heart Failure: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Antatt)

Fase

Kontakter og plasseringer

Studiekontakt

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Studierekorddatoer

Studer hoveddatoer

Studiestart (Antatt)

Primær fullføring (Antatt)

Studiet fullført (Antatt)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt