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

Phase 3

Terminated

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

• Registration Number: NCT01439789
• Lead Sponsor: 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.

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 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: 146

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
NT-proBNP	30 days

Secondary Outcome Measures

Name	Time	Method
NT-proBNP	90 days
Six Minutes Walk Distance	30 days and 90 days
NYHA classification	30 days and 90 days
Quality of Life	30 days and 90 days

Trial Locations

Locations (21)

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

Bethune Peace Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Teda International Cardiovascular Hospital; 🇨🇳 Tianjin, Hebei, China

Daqing Oilfield General Hospital; 🇨🇳 Daqing, Heilongjiang, China

The First Hospital of Harbin Medical University; 🇨🇳 Haerbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

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

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