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

Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients

This study has been terminated.
(Sponsor has designed another study with different endpoint to replace the current study)
Sponsor:
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01439789
First received: September 21, 2011
Last updated: August 1, 2012
Last verified: July 2012

September 21, 2011
August 1, 2012
June 2011
June 2012   (final data collection date for primary outcome measure)
NT-proBNP [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01439789 on ClinicalTrials.gov Archive Site
  • NT-proBNP [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Six Minutes Walk Distance [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
  • NYHA classification [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure

Multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on serum NT-proBNP, as well as safety in patients with chronic heart failure.

N-terminal proNBP (NT-proBNP) has been proved to be an independent prognostic factor for the long-term prognosis of chronic heart failure patients.RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it. It has been found that rhNRG-1 effectively decreased the serum level of NT-proBNP,and is tolerated in the effective dosages groups.The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively decrease the serum level of NT-proBNP and is tolerated in patients with chronic 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
  • Drug: Placebo
    day1~day10:0.6ug/kg/day,10hours per day for vein infusion
  • Active Comparator: rhNRG-1
    Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
    Intervention: Drug: rhNRG-1
  • Placebo Comparator: Plaebo
    Excipient placebo in addition to basic therapy of chronic heart failure
    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
146
December 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age between 18 and 75, both sex.
  2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
  3. NYNA functional class II~III.
  4. Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
  5. Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
  6. Capable of signing the informed consent form.

Exclusion Criteria:

  1. Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
  2. Ischemic heart failure without recanalization or with recanalization in recent six months.
  3. Cardiac surgery or cerebrovascular accident within recent six months.
  4. Preparing for heart transplantation or has received CRT treatment.
  5. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
  6. Patients need mechanical ventilation.
  7. Systolic blood pressure <90mmHg or >160mmHg.
  8. Patients with acute hemodynamic disorder or decompensation in the last 1 month.
  9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
  10. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  11. Pregnant or plan to pregnant.
  12. Unmarried or married but not procreated women at child-bearing age.
  13. Subject with a life expectancy less than 6 months as assessed by the investigator.
  14. Patients who participated in any clinical trial in the recent three months.
  15. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  16. 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.
  17. 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 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01439789
ZS-01-304
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