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

Purpose

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

Condition	Intervention	Phase
Chronic Heart Failure	Drug: rhNRG-1 Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Zensun Sci. & Tech. Co., Ltd.:

Primary Outcome Measures:

All-cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

sudden death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
death caused by cardiovascular events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
rehospitalization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
hospitalization caused by worsening heart failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
cardiac function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
NYHA functional classification [ Time Frame: 1 year ] [ Designated as safety issue: No ]
6 minute walking distance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	1600
Study Start Date:	February 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo placebo in addition to standard therapy	Drug: Placebo 10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
Experimental: rhNRG-1 rhNRG-1 in addition to standard therapy	Drug: rhNRG-1 10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks

Detailed Description:

The mortality of chronic heart failure patients remains high, in spite of current 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, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 75, both sex.
Left ventricular ejection fraction (LVEF)≤40% (ECHO).
NYNA functional class II OR III.
Diagnosed as chronic systolic heart failure (history, symptoms, signs), no in-hospital history in the last one month.
Receiving standard therapy for chronic heart failure, reach target dose or max tolerable dose for one month, or has not changed the dose for the last one month.
Capable of signing the informed consent form.

Exclusion Criteria:

new chronic heart failure patients, or patients receiving standard therapy on chronic heart failure for less than 3 months.
NYNA functional class I OR IV.
Patients with acute MI, hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, primary or secondary severe pulmonary artery hypertension.
Ischemic heart failure without recanalization or with recanalization in recent six months.
acute MI in the last 3 months.
unstable angina.
Patients with acute pulmonary edema or acute hemodynamic disorder.
Chronic heart failure patients with acute hemodynamic disorder or acute decompensation in the last 1 month.
Patients with right heart failure caused by pulmonary disease.
Patients diagnosed with pericardial effusion or pleural effusion, or evidenced by B-type ultrasonic (>50ml).
Cardiac surgery or cerebrovascular accident within recent six months.
Preparing for heart transplantation or CRT, or has received CRT.
Serious ventricular arrhythmia (multi-morphological premature ventricular contraction more than 5 times/min, frequent paroxysmal ventricular tachycardia or triple rate).
Serious hepatic or renal dysfunction (Cr＞2.0mg/dl, AST or ALT 5 times above the normal upper limit).
Serum potassium <3.2 mmol/L or >5.5 mmol/L.
Systolic blood pressure <90mmHg or >160mmHg.
Pregnant or plan to pregnant.
Patients who participated in any clinical trial in the recent three months.
Subject with a life expectancy less than 6 months as assessed by the investigator.
Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism),lower limb defects, or deaf-mute.
History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
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.
Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541202

Contacts

Contact: Xinyan Li, Ph.D, MD

86-21-50802627 ext 109

xinyanl@zensun.com

Show 46 Study Locations

Sponsors and Collaborators

Zensun Sci. & Tech. Co., Ltd.

Investigators

Principal Investigator:

Runlin Gao, MD, Ph.D

Cardiovascular Institute and Fuwai Hospital

More Information

No publications provided

Responsible Party:	Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01541202 History of Changes
Other Study ID Numbers:	ZS-01-305
Study First Received:	February 23, 2012
Last Updated:	February 28, 2012
Health Authority:	China: Food and Drug Administration

Keywords provided by Zensun Sci. & Tech. Co., Ltd.:

chronic heart failure
neuregulin
mortality

Additional relevant MeSH terms:

Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013