A Phase 2b, Double-Blind, Placebo-Controlled, Multinational, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects with Heart Failure

Service: Trial Number:
100-12
Principal Investigator: Conducted at:
Long Beach Memorial
Currently enrolling additional patients:
Yes

Celladon Corporation (Celladon) is investigating MYDICAR® (AAV1/SERCA2a), a gene transfer product, in the treatment of patients with moderate to advanced heart failure due to systolic dysfunction (failure of the pump function of the heart). Research in basic mechanism of heart muscle dysfunction in heart failure (HF) has identified a deficiency of SERCA2a protein in the cardiomyocytes (cells that make up the heart muscle) as a key characteristic in the disease. SERCA2a plays a pivotal role in maintaining adequate calcium levels in myocardial cells and for the relaxation and contraction of cardiomyocytes. The goal of MYDICAR® therapy is to restore Ca2+ cycling in cardiomyocytes by normalizing SERCA2a protein levels in advanced HF patients. It is believed that MYDICAR will improve heart muscle function and improve coronary artery blood flow. MYDICAR® is delivered via Antegrade Epicardial Coronary Artery Infusion (AECAI – injection of the drug into the coronary artery) in an outpatient cardiac catheterization laboratory. This is a placebo-controlled study. Subjects will be randomized in parallel in a ratio of 1:1. Subjects are expected to continue existing maximal, optimized heart failure therapies. These therapies should continue throughout the trial.

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