Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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 cells to restore their structure and function. This study will investigate the safety and efficacy of rhNRG-1 to treat stable chronic heart failure.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zensun Sci. & Tech. Co., Ltd.
• Collaborator: Zensun USA Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.