Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients

Chronic Systolic Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01439893
• Other study ID #: ZS-01-303
• Status: Terminated
• Phase: Phase 3
• First received: September 21, 2011
• Last updated: December 19, 2017
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Zensun Sci. & Tech. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Systolic Heart Failure
• Heart Failure
• Heart Failure, Systolic

Intervention

Drug:
• rhNRG-1
day1~day10:0.6ug/kg/day,10hours per day for vein infusion
• Placebo
day1~day10:0.6ug/kg/day,10hours per day for vein infusion

Locations

Country	Name	City	State
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	Cardiovascular Institute and Fuwai Hospital	Beijing	Beijing
China	General Hospital of Chinese People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zensun Sci. & Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Ejection Fraction		30 days
Secondary	Left Ventricular Ejection Fraction		90 days
Secondary	N-terminal pro-BNP		30 days and 90 days