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
  Purpose

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.


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 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:
  • NT-proBNP [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 146
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: Plaebo
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:

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.

  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 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).
  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: NCT01439789

Locations
China, Beijing
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing, China
China, Hebei
Bethune Peace Hospital
Shijiazhuang, Hebei, China
Teda International Cardiovascular Hospital
Tianjin, Hebei, China
China, Heilongjiang
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The First Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
China, Jiangsu
Sichuan Provincial People`s Hospital
Chengdu, Jiangsu, China
The Second Hospital affiliated to Suzhou University
Suzhou, Jiangsu, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Affiliate Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
China, Jilin
The Second Hospital of Jilin University
Changchun, Jilin, China
China, Liaoning
The First Hospital affiliated to Dalian Medical University
Dalian, Liaoning, China
The first affiliated hospital of Liaoning medical college
Jinzhou, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai, China
China, Sichuan
The Xinqiao Hospital of Third Military Medical University
Chongqing, Sichuan, China
China, Yunnan
Kunming General Hospital of Chengdu Military Region
Kunming, Yunnan, 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: NCT01439789     History of Changes
Other Study ID Numbers: ZS-01-304
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
NT-proBNP

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

ClinicalTrials.gov processed this record on July 29, 2014