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

NCT01439893 | Terminated Phase 3 DMC

• 1 other identifier: ZS-01-303
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Systolic Heart Failure

Keywords

Chronic heart failure; rhNRG-1; Cardiac remodeling

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction

  30 days

Secondary Outcomes (2)

• Left Ventricular Ejection Fraction

  90 days

• N-terminal pro-BNP

  30 days and 90 days

Study Arms (2)

rhNRG-1

ACTIVE COMPARATOR

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

Drug: rhNRG-1

Placebo

PLACEBO COMPARATOR

Excipient placebo in addition to basic therapy of chronic heart failure

Drug: Placebo

Interventions

rhNRG-1 DRUG

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

rhNRG-1

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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\~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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zensun Sci. & Tech. Co., Ltd.: lead

Study Sites (4)

Beijing Anzhen Hospital, Affiliate of Capital University of Medical Sciences

Beijing, Beijing Municipality, China

Location

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

Beijing, Beijing Municipality, China

Location

Cardiovascular Institute and Fuwai Hospital

Beijing, Beijing Municipality, China

Location

General Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Location

Study Officials

• Runlin Gao, MD, Ph.D

  Cardiovascular Institute and Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 23, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 21, 2017

Record last verified: 2012-07

Locations

CN (4)