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

19. desember 2017 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

331

Fase

  • Fase 3

Kontakter og plasseringer

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

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

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

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: placebo
Legemiddel: 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
Eksperimentell: rhNRG-1
recombinant human neuregulin-1
Legemiddel: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
alle forårsaker dødelighet
Tidsramme: ett år
ett år

Samarbeidspartnere og etterforskere

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

Sponsor

Zensun Sci. & Tech. Co., Ltd.

Etterforskere

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

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

1. april 2010

Primær fullføring (Faktiske)

1. juni 2012

Studiet fullført (Faktiske)

1. august 2012

Datoer for studieregistrering

Først innsendt

25. mai 2010

Først innsendt som oppfylte QC-kriteriene

26. mai 2010

Først lagt ut (Anslag)

27. mai 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. desember 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. desember 2017

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • ZS-01-301

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. .

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