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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Systolic 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 Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

Primary Outcome Measures:
  • Left Ventricular Ejection Fraction [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: rhNRG-1
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
 Drug: rhNRG-1
day1~day10:0.6ug/kg/day,10hours per day for vein infusion
Placebo Comparator: Placebo
Excipient placebo in addition to basic therapy of chronic heart failure
 Drug: Placebo
day1~day10:0.6ug/kg/day,10hours per day for vein infusion

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439893

Locations
China, Beijing
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing, China
Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing, China
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, Beijing, China
General Hospital of Chinese People's Liberation Army
Beijing, Beijing, China
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: NCT01439893     History of Changes
Other Study ID Numbers: ZS-01-303
Study First Received: September 21, 2011
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
Cardiac remodeling

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013