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Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients

19. december 2017 opdateret af: Zensun Sci. & Tech. Co., Ltd.

A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The mortality of chronic heart failure patients remains high, in spite of recent treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

331

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Beijing, Kina
        • Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
      • Beijing, Kina
        • Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
      • Beijing, Kina
        • Cardiovascular Institute and Fuwai Hospital
      • Shanghai, Kina
        • Huashan Hospital Affiliated to Fudan University
      • Shanghai, Kina
        • Renji Hospital, Medical School of Shanghai Jiaotong University
      • Shanghai, Kina
        • The first people's hospitial of Shanghai
      • Shanghai, Kina
        • The Sixth People's Hospital, Shanghai Jiaotong University
    • Beijing
      • Beijing, Beijing, Kina
        • General Hospital of Chinese People's Liberation Army
    • Gansu
      • Lanzhou, Gansu, Kina
        • The First Hospital affiliated to Lanzhou University
    • Hainan
      • Haikou, Hainan, Kina
        • Haikou Municipal Peoples Hospital
    • Hebei
      • Shijiazhuang, Hebei, Kina
        • Bethune International Peace Hospital
      • Tianjin, Hebei, Kina
        • Teda International Cardiovascular Hospital
    • Heilongjiang
      • Daqing, Heilongjiang, Kina
        • Daqing Oilfield General hospital
      • Haerbin, Heilongjiang, Kina
        • The First Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, Kina
        • The First hospital affiliated to Zhengzhou University
    • Hubei
      • Wuchang, Hubei, Kina
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, Kina
        • Tongji Hospital affiliated to Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Kina
        • The Second Xiangya Hospital of Central South University
      • Changsha, Hunan, Kina
        • Hunan Provincial People's Hospital
    • Jiangsu
      • Jiangyin, Jiangsu, Kina
        • Jiangsu Jiangyin People's Hospital
      • Nanjing, Jiangsu, Kina
        • Nanjing Drum Tower Hospital
      • Nanjing, Jiangsu, Kina
        • Zhongda Hospital, Southeast University
      • Suzhou, Jiangsu, Kina
        • The Second Hospital Affiliated To Suzhou University
      • Xuzhou, Jiangsu, Kina
        • The Affiliated Hospital of Xuzhou Medical School
      • Yangzhou, Jiangsu, Kina
        • North Jiangsu People's Hospital
      • Zhenjiang, Jiangsu, Kina
        • The Affiliate Hospital of Jiangsu University
    • Jilin
      • Changchun, Jilin, Kina
        • The Second Hospital affiliated to Jilin University
    • Liaoning
      • Dalian, Liaoning, Kina
        • The First Hospital affiliated to Dalian Medical University
      • Jinzhou, Liaoning, Kina
        • The first affiliated hospital of Liaoning medical college
      • Shenyang, Liaoning, Kina
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, Kina
        • Liaoning Provincial People's Hospital
      • Shenyang, Liaoning, Kina
        • The First Hospital of China Medical Hospital
    • Shandong
      • Jinan, Shandong, Kina
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, Kina
        • The Second Hospital of Shandong University
    • Shanxi
      • Xi'an, Shanxi, Kina
        • Shanxi Provincial People's Hospital
      • Xi'an, Shanxi, Kina
        • The second hospital of Xi'an jiaotong university
    • Sichuan
      • Chendu, Sichuan, Kina
        • Sichuan Provincial People's Hospital
      • Chendu, Sichuan, Kina
        • Huaxi Hospital of Sichuan University
      • Chongqin, Sichuan, Kina
        • The Xinqiao Hospital of Third Military Medical University
    • Yunnan
      • Kunming, Yunnan, Kina
        • Kunming General Hospital of Chengdu Military Region
      • Kunming, Yunnan, Kina
        • The Second hospital affiliated to Kunming Medical and Pharmaceutical College
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • Sir Run Run Shaw Hospital affiliated to School of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, Kina
        • The First Hospital affiliated to School of Medicine, Zhejiang University

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

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age between 18 and 80, both sex.
  2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  3. NYNA functional class III~Ⅳ.
  4. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
  5. Capable of signing the informed consent form.

Exclusion Criteria:

  1. Patients with acute pulmonary edema or acute hemodynamic disorder.
  2. Patients with right heart failure caused by pulmonary disease.
  3. Patients diagnosed with pericardial effusion or pleural effusion.
  4. Patients with myocardial infarction during the preceding 3 months.
  5. Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
  6. Unstable angina pectoris.
  7. Cardiac surgery or cerebrovascular accident within recent six months.
  8. Preparing for heart transplantation.
  9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
  10. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
  11. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  12. Systolic blood pressure <90mmHg or >160mmHg.
  13. Pregnant or plan to pregnant.
  14. Patients who participated in any clinical trial in the recent three months.
  15. Subject with a life expectancy less than 3 months as assessed by the investigator.
  16. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
  17. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  18. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
  19. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: placebo
Medicin: placebo
day1~day10:0.6ug/kg/day,10hours per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes per time per week for vein injection
Eksperimentel: rhNRG-1
recombinant human neuregulin-1
Medicin: rhNRG-1
day1~day10:0.6ug/kg/day,10hours per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes per time per week for vein injection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
alle forårsager dødelighed
Tidsramme: et år
et år

Samarbejdspartnere og efterforskere

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

Sponsor

Zensun Sci. & Tech. Co., Ltd.

Efterforskere

  • Ledende efterforsker: Runlin Gao, MD,Ph.D, Cardiovascular Institute and Fuwai Hospital

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

1. april 2010

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. august 2012

Datoer for studieregistrering

Først indsendt

25. maj 2010

Først indsendt, der opfyldte QC-kriterier

26. maj 2010

Først opslået (Skøn)

27. maj 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. december 2017

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ZS-01-301

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 .

Kliniske forsøg med Kronisk hjertesvigt

Kliniske forsøg med rhNRG-1

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Tunisia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner