Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

NCT01214096 | Terminated Phase 3 DMC

• 1 other identifier: ZS-01-302
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

Conditions

Chronic Heart Failure

Keywords

Chronic Heart failure; rhNRG-1; MRI

Outcome Measures

Primary Outcomes (1)

• cardiac function measured by MRI

  30 days

Secondary Outcomes (1)

• cardiac function

  baseline, 30 days, 90day and180 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

rhNRG-1

EXPERIMENTAL

recombinant human neuregulin-1

Drug: rhNRG-1

Interventions

rhNRG-1 DRUG

Subcutaneous Administration:0.6ug/kg/day for 10days

rhNRG-1

placebo DRUG

Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days

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: 18-75 years old, no limitation in gender;
• Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO);
• Patients with chronic heart failure (NYHA class II or III);
• In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable;
• Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month;
• Understand and sign the informed consent form;

You may not qualify if:

• Atrial fibrillation;
• Subject underwent cardiac pacemaker treatment;
• Subject underwent metal graft treatment;
• Claustrophobia;
• Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension;
• Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months;
• Subject underwent cardiac surgery or cerebrovascular events within the previous six months;
• Subjects who plan to have cardiac transplantation;
• Severe hepatic and renal insufficiency (serum creatinine\>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range);
• Subject needs mechanical ventilation;
• Systolic blood pressure \< 90mmHg, or \> 160mmHg;
• Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month;
• Mobitz Type II or III° atrial ventricular block，severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia);
• Serum potassium\<3.2mmol/L, or\>5.5mmol/L;
• Female subject is pregnant or plan to become pregnant

Sponsors & Collaborators

• Zensun Sci. & Tech. Co., Ltd.: lead

Study Sites (4)

Beijing Anzhen Hospital of Capital University of Medical Sciences

Beijing, China

Location

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Location

Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

General Hospital of People's Liberation Army

Beijing, China

Location

Study Officials

• Runlin Gao

  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 28, 2010
• First Posted: October 4, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 21, 2017

Record last verified: 2017-11

Locations

CN (4)