NCT01541202|TerminatedPhase 3DMC

Study Stopped

Sponsor has designed another study to replace the current study

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

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

Zensun Sci. & Tech. Co., Ltd.ClinicalTrials.gov

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1 other identifier

ZS-01-305

Study Type

interventional

Target

679

Locations

1 country

Sites

Timeline

RegisteredFeb 2012

StartedFeb 2012

CompletionAug 2017

Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

679

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Feb 2012

Longer than P75 for phase_3

Geographic Reach

1 country

46 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.5 years study duration

Study Start

First participant enrolled

February 1, 2012

Completed

22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed

5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed

Last Updated

December 21, 2017

Status Verified

February 1, 2012

Enrollment Period

5.5 years

First QC Date

February 23, 2012

Last Update Submit

December 19, 2017

Conditions

Chronic Heart Failure

Keywords

chronic heart failureneuregulinmortality

Outcome Measures

Primary Outcomes (1)

All-cause mortality
1 year

Secondary Outcomes (8)

sudden death
1 year
death caused by cardiovascular events
1 year
rehospitalization
1 year
hospitalization caused by worsening heart failure
1 year
cardiac function
1 year
+3 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo in addition to standard therapy

Drug: Placebo

rhNRG-1

EXPERIMENTAL

rhNRG-1 in addition to standard therapy

Drug: rhNRG-1

Interventions

rhNRG-1DRUG

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

rhNRG-1

PlaceboDRUG

10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+8 more criteria

Contact the study team to confirm eligibility.