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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Heart Failure

In brief

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.

Key facts

Study ID

NCT01251406

Run by

Zensun Sci. & Tech. Co., Ltd.

People needed

67

Starts

2012-01-01

Expected to finish

2014-03-01

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Diego — La Jolla, California, United States
• Metabolic Clinic and Research Center — Los Angeles, California, United States
• USC Cardiovascular Division — Los Angeles, California, United States
• Orange County Research Center — Tustin, California, United States
• University of Colorado Denver — Denver, Colorado, United States
• Clearwater Cardiovascular & Interventional Consultants, MD, PA — Clearwater, Florida, United States
• University of South Florida — Tampa, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• MedPharmics, LLC. — Kenner, Louisiana, United States
• Benchmark Research — Metairie, Louisiana, United States
• East Texas Cardiology — Houston, Texas, United States
• The Medical Center of Plano — Plano, Texas, United States
• Sentara Cardiovascular Research Institute — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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