Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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


Condition Intervention Phase
Chronic Heart Failure
Drug: rhNRG-1
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Zensun Sci. & Tech. Co., Ltd.:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 331
Study Start Date: April 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhNRG-1
recombinant human neuregulin-1
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
Placebo Comparator: placebo
placebo
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131637

  Show 43 Study Locations
Sponsors and Collaborators
Zensun Sci. & Tech. Co., Ltd.
Investigators
Principal Investigator: Runlin Gao, MD,Ph.D Cardiovascular Institute and Fuwai Hospital
  More Information

No publications provided

Responsible Party: Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01131637     History of Changes
Other Study ID Numbers: ZS-01-301
Study First Received: May 25, 2010
Last Updated: August 1, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
chronic heart failure
rhNRG-1
mortality

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2014