Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure (NCT01251406) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure
United States67 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 interrogati…