Back to results

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

Primary Purpose

Chronic Systolic Heart Failure

Status

Terminated

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

rhNRG-1

Placebo

About this trial

This is an interventional treatment trial for Chronic Systolic Heart Failure focused on measuring Chronic heart failure, rhNRG-1, Cardiac remodeling

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age between 18 and 75, both sex.
Left ventricular ejection fraction (LVEF)≤40% (ECHO).
NYNA functional class II~III.
Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
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.
Capable of signing the informed consent form.

Exclusion Criteria:

Patients with atrial fibrillation.
Patients with a pacemaker.
Patient with a metallic implant.
Patient with Claustrophobia.
Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
Ischemic heart failure without recanalization or with recanalization in recent six months.
Cardiac surgery or cerebrovascular accident within recent six months.
Preparing for heart transplantation or has received CRT treatment.
Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
Patients need mechanical ventilation.
Systolic blood pressure <90mmHg or >160mmHg.
Patients with acute hemodynamic disorder or decompensation in the last 1 month.
Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
Serum potassium <3.2 mmol/L or >5.5 mmol/L.
Pregnant or plan to pregnant.
Unmarried or married but not procreated women at child-bearing age.
Subject with a life expectancy less than 6 months as assessed by the investigator.
Patients who participated in any clinical trial in the recent three months.
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).

Sites / Locations

Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences
Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences
Cardiovascular Institute and Fuwai Hospital
General Hospital of Chinese People's Liberation Army

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

rhNRG-1

Placebo

Arm Description

Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure

Excipient placebo in addition to basic therapy of chronic heart failure

Outcomes

Primary Outcome Measures

Left Ventricular Ejection Fraction

Secondary Outcome Measures

Left Ventricular Ejection Fraction

N-terminal pro-BNP

Full Information

NCT ID

NCT01439893

First Posted

September 21, 2011

Last Updated

December 19, 2017

Sponsor

Zensun Sci. & Tech. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01439893

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor has designed another study with different endpoint to replace the current study

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zensun Sci. & Tech. Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Systolic Heart Failure

Keywords

Chronic heart failure, rhNRG-1, Cardiac remodeling

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rhNRG-1

Arm Type

Active Comparator

Arm Description

Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Excipient placebo in addition to basic therapy of chronic heart failure

Intervention Type

Drug

Intervention Name(s)

rhNRG-1

Intervention Description

day1~day10:0.6ug/kg/day,10hours per day for vein infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

day1~day10:0.6ug/kg/day,10hours per day for vein infusion

Primary Outcome Measure Information:

Title

Left Ventricular Ejection Fraction

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Left Ventricular Ejection Fraction

Time Frame

90 days

Title

N-terminal pro-BNP

Time Frame

30 days and 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 18 and 75, both sex. Left ventricular ejection fraction (LVEF)≤40% (ECHO). NYNA functional class II~III. Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month. 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. Capable of signing the informed consent form. Exclusion Criteria: Patients with atrial fibrillation. Patients with a pacemaker. Patient with a metallic implant. Patient with Claustrophobia. Patients with acute myocardial infarction, Hypertrophic cardiomyopathy, constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension. Ischemic heart failure without recanalization or with recanalization in recent six months. Cardiac surgery or cerebrovascular accident within recent six months. Preparing for heart transplantation or has received CRT treatment. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr>2.0mg/dl, AST or ALT 5 times above the normal upper limit). Patients need mechanical ventilation. Systolic blood pressure <90mmHg or >160mmHg. Patients with acute hemodynamic disorder or decompensation in the last 1 month. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia). Serum potassium <3.2 mmol/L or >5.5 mmol/L. Pregnant or plan to pregnant. Unmarried or married but not procreated women at child-bearing age. Subject with a life expectancy less than 6 months as assessed by the investigator. Patients who participated in any clinical trial in the recent three months. 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Runlin Gao, MD, Ph.D

Organizational Affiliation

Cardiovascular Institute and Fuwai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Beijing Chao Yang Hospital, Affiliate of Capital University of Medical Sciences

City

Beijing

State/Province

Beijing

Country

China

Facility Name

Cardiovascular Institute and Fuwai Hospital

City

Beijing

State/Province

Beijing

Country

China

Facility Name

General Hospital of Chinese People's Liberation Army

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs