Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic 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:
NCT01439893
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)
Left Ventricular Ejection Fraction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01439893 on ClinicalTrials.gov Archive Site
  • Left Ventricular Ejection Fraction [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • N-terminal pro-BNP [ Time Frame: 30 days and 90 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic 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

This is a 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 cardiac remodeling, as well as safety in patients with chronic heart failure.

RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively improved the heart function, and is tolerated in the effective dosage groups. The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively improve the cardiac remodeling 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 Systolic 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: Placebo
    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
14
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 atrial fibrillation.
  2. Patients with a pacemaker.
  3. Patient with a metallic implant.
  4. Patient with Claustrophobia.
  5. Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
  6. Ischemic heart failure without recanalization or with recanalization in recent six months.
  7. Cardiac surgery or cerebrovascular accident within recent six months.
  8. Preparing for heart transplantation or has received CRT treatment.
  9. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
  10. Patients need mechanical ventilation.
  11. Systolic blood pressure <90mmHg or >160mmHg.
  12. Patients with acute hemodynamic disorder or decompensation in the last 1 month.
  13. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
  14. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
  15. Pregnant or plan to pregnant.
  16. Unmarried or married but not procreated women at child-bearing age.
  17. Subject with a life expectancy less than 6 months as assessed by the investigator.
  18. Patients who participated in any clinical trial in the recent three months.
  19. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
  20. 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.
  21. 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
 
NCT01439893
ZS-01-303
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