Status:
COMPLETED
Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure
Lead Sponsor:
Zensun Sci. & Tech. Co., Ltd.
Collaborating Sponsors:
Zensun USA Inc.
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1 (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged heart muscle cell...
Detailed Description
This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure. ...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Male or female subjects.
- Have chronic heart failure defined as NYHA classification of II or III.
- Be on a stable regimen of ACEI/ARB and/or beta-blocker 3 months prior to receiving study medication and are expected to remain on a stable HF medication regime throughout the duration of the trial.
- Left ventricular ejection fraction (LVEF) of \< 35% as determined at screening by 2-D echocardiography.
- Is able to understand and provide informed consent.
- If subject has dilated cardiomyopathy, ischemic heart disease or corrected valvular heart disease, and had surgery to repair or replace value, the surgery must have been performed 3 months prior to receiving study medication and the surgical area is functioning normally.
- Proper birth control must be used at least 3 weeks prior to the study (women only), during the infusion period of study drug (men and women), 4-weeks after study drug administration (men and women) and the remaining 11 months in the study follow-up (women). Women must have a negative pregnancy test at screening.
- No greater than mild pericardial effusion \< 0.5 cm on echocardiography (roughly corresponds to \< 100 mL).
- Have an implantable cardioverter-defibrillator (ICD). The ICD should have been implanted at least 3 months prior to receiving study medication. Patients should undergo interrogation of their ICDs between 1 and 7 days before randomization to drug for the previous thirty (30) days. This interrogation would include surveillance for ventricular arrhythmias as well as assessment of ICD discharge(s) and/or anti-tachycardia pacing.
Exclusion
- Has chronic heart failure classified as NYHA Class I or IV.
- Has a history of any malignancy or positive test as specified in the pre-cancer screening.
- Have other conditions which in the opinion of the investigator preclude participation in the study, e.g. serious co-morbidity, known or suspected substance abuse or non-compliance.
- Has a body weight \>350lbs.
- Has had any cause hospitalization 30 days prior to screening.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01251406
Start Date
January 1 2012
End Date
March 1 2014
Last Update
February 10 2025
Active Locations (13)
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1
University of California, San Diego
La Jolla, California, United States, 92037
2
Metabolic Clinic and Research Center
Los Angeles, California, United States, 90033
3
USC Cardiovascular Division
Los Angeles, California, United States, 90033
4
Orange County Research Center
Tustin, California, United States, 92780