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

Sponsor
Zensun Sci. & Tech. Co., Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01439789
Collaborator
(none)
146
Enrollment
21
Locations
2
Arms
12
Duration (Months)
7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Jun 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. NT-proBNP [30 days]

Secondary Outcome Measures

  1. NT-proBNP [90 days]

  2. Six Minutes Walk Distance [30 days and 90 days]

  3. NYHA classification [30 days and 90 days]

  4. Quality of Life [30 days and 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cardiovascular Institute and Fuwai Hospital Beijing Beijing China
2 Bethune Peace Hospital Shijiazhuang Hebei China
3 Teda International Cardiovascular Hospital Tianjin Hebei China
4 Daqing Oilfield General Hospital Daqing Heilongjiang China
5 The First Hospital of Harbin Medical University Haerbin Heilongjiang China
6 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
7 The Second Xiangya Hospital of Central South University Changsha Hunan China
8 Sichuan Provincial People's Hospital Chengdu Jiangsu China
9 The Second Hospital affiliated to Suzhou University Suzhou Jiangsu China
10 North Jiangsu People's Hospital Yangzhou Jiangsu China
11 The Affiliate Hospital of Jiangsu University Zhenjiang Jiangsu China
12 The Second Hospital of Jilin University Changchun Jilin China
13 The First Hospital affiliated to Dalian Medical University Dalian Liaoning China
14 The first affiliated hospital of Liaoning medical college Jinzhou Liaoning China
15 Liaoning Provincial People's Hospital Shenyang Liaoning China
16 Shengjing Hospital of China Medical University Shenyang Liaoning China
17 Qilu Hospital of Shandong University Jinan Shandong China
18 Shanghai First People's Hospital Shanghai Shanghai China
19 Shanghai Sixth People's Hospital Shanghai Shanghai China
20 The Xinqiao Hospital of Third Military Medical University Chongqing Sichuan China
21 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01439789
Other Study ID Numbers:
  • ZS-01-304
First Posted:
Sep 23, 2011
Last Update Posted:
Dec 21, 2017
Last Verified:
Jul 1, 2012
Keywords provided by Zensun Sci. & Tech. Co., Ltd.
Chronic Heart Failure
rhNRG-1
NT-proBNP
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Dec 21, 2017