Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients

Zensun

Status and phase: Terminated; Phase 3

Conditions: Chronic Heart Failure

Treatments: Drug: rhNRG-1; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131637

ZS-01-301

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Full description

The mortality of chronic heart failure patients remains high, in spite of recent treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Enrollment: 331 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18 and 80, both sex.
2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
3. NYNA functional class III~Ⅳ.
4. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
5. Capable of signing the informed consent form.

Exclusion criteria

1. Patients with acute pulmonary edema or acute hemodynamic disorder.
2. Patients with right heart failure caused by pulmonary disease.
3. Patients diagnosed with pericardial effusion or pleural effusion.
4. Patients with myocardial infarction during the preceding 3 months.
5. Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
6. Unstable angina pectoris.
7. Cardiac surgery or cerebrovascular accident within recent six months.
8. Preparing for heart transplantation.
9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
10. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
11. Serum potassium <3.2 mmol/L or >5.5 mmol/L.
12. Systolic blood pressure <90mmHg or >160mmHg.
13. Pregnant or plan to pregnant.
14. Patients who participated in any clinical trial in the recent three months.
15. Subject with a life expectancy less than 3 months as assessed by the investigator.
16. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
17. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
18. 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.
19. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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331 participants in 2 patient groups, including a placebo group

rhNRG-1

Experimental group

Description:

recombinant human neuregulin-1

Treatment:

Drug: rhNRG-1

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo