Clinical trial NCT01439789: Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
rhNRG-1
NT-proBNP
Lead sponsor: Zensun Sci. & Tech. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: NT-proBNP
timeFrame: 30 days
Secondary outcomes:
measure: NT-proBNP
timeFrame: 90 days
measure: Six Minutes Walk Distance
timeFrame: 30 days and 90 days
measure: NYHA classification
timeFrame: 30 days and 90 days
measure: Quality of Life
timeFrame: 30 days and 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital
state: Beijing
city: Shijiazhuang
country: China
facility: Bethune Peace Hospital
state: Hebei
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
state: Hebei
city: Daqing
country: China
facility: Daqing Oilfield General Hospital
state: Heilongjiang
city: Haerbin
country: China
facility: The First Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Hospital affiliated to Suzhou University
state: Jiangsu
city: Yangzhou
country: China
facility: North Jiangsu People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: The Affiliate Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Hospital affiliated to Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: The first affiliated hospital of Liaoning medical college
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Provincial People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Chongqing
country: China
facility: The Xinqiao Hospital of Third Military Medical University
state: Sichuan
city: Kunming
country: China
facility: Kunming General Hospital of Chengdu Military Region
state: Yunnan
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital
name: Runlin Gao, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: