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

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. Identifier: NCT01439789
Recruitment Status : Terminated (Sponsor has designed another study with different endpoint to replace the current study)
First Posted : September 23, 2011
Last Update Posted : December 21, 2017
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Heart Failure Drug: rhNRG-1 Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
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
Study Start Date : June 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. NT-proBNP [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. NT-proBNP [ Time Frame: 90 days ]
  2. Six Minutes Walk Distance [ Time Frame: 30 days and 90 days ]
  3. NYHA classification [ Time Frame: 30 days and 90 days ]
  4. Quality of Life [ Time Frame: 30 days and 90 days ]

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

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).

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 identifier (NCT number): NCT01439789

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
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
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.
Principal Investigator: Runlin Gao, MD, Ph.D Cardiovascular Institute and Fuwai Hospital

Responsible Party: Zensun Sci. & Tech. Co., Ltd. Identifier: NCT01439789     History of Changes
Other Study ID Numbers: ZS-01-304
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: July 2012

Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases