Clinical trial NCT01439893: Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic 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 Systolic Heart Failure
Keywords: Chronic heart failure
rhNRG-1
Cardiac remodeling
Lead sponsor: Zensun Sci. & Tech. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-09-23
Enrollment: 14
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: 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.

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 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).

Primary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: 30 days
Secondary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: 90 days
measure: N-terminal pro-BNP
timeFrame: 30 days and 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: General Hospital of Chinese People's Liberation Army
state: Beijing
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital
name: Runlin Gao, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: