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

This study has been terminated.
(Sponsor has designed another study to replace the current study)
Sponsor:
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01131637
First received: May 25, 2010
Last updated: August 1, 2012
Last verified: July 2012

May 25, 2010
August 1, 2012
April 2010
June 2012   (final data collection date for primary outcome measure)
all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01131637 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure
  • Drug: 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
  • Drug: 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
  • Experimental: rhNRG-1
    recombinant human neuregulin-1
    Intervention: Drug: rhNRG-1
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
331
December 2012
June 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01131637
ZS-01-301
Yes
Zensun Sci. & Tech. Co., Ltd.
Zensun Sci. & Tech. Co., Ltd.
Not Provided
Principal Investigator: Runlin Gao, MD,Ph.D Cardiovascular Institute and Fuwai Hospital
Zensun Sci. & Tech. Co., Ltd.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP