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

Phase 3

Terminated

• Conditions: Chronic Systolic Heart Failure
• Interventions: Drug: Placebo; Drug: rhNRG-1

• Registration Number: NCT01439893
• Lead Sponsor: Zensun Sci. & Tech. Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Excipient placebo in addition to basic therapy of chronic heart failure
rhNRG-1	rhNRG-1	Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure

Primary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction	30 days

Secondary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction	90 days
N-terminal pro-BNP	30 days and 90 days

Trial Locations

Locations (4)

Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Cardiovascular Institute and Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences; 🇨🇳 Beijing, Beijing, China

General Hospital of Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China