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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:
ClinicalTrials.gov Identifier:
NCT01439893
First Posted: September 23, 2011
Last Update Posted: August 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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

Primary Outcome Measures:
  • Left Ventricular Ejection Fraction [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Left Ventricular Ejection Fraction [ Time Frame: 90 days ]
  • N-terminal pro-BNP [ Time Frame: 30 days and 90 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439893


Locations
China, Beijing
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
Cardiovascular Institute and Fuwai Hospital
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

Responsible Party: Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01439893     History of Changes
Other Study ID Numbers: ZS-01-303
First Submitted: September 21, 2011
First Posted: September 23, 2011
Last Update Posted: August 3, 2012
Last Verified: July 2012

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