Heart Failure, Congestive Clinical Trial
Official title:
A Phase 1/2 Trial of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure in Two Stages (Open-Label, Sequential Dose-Escalation Cohorts and Randomized, Double-Blind, Placebo-Controlled, Parallel Cohorts)
The study is divided into 2 parts. In the first part, the safety of the gene transfer agent MYDICAR® will be evaluated. In the second part, the ability of MYDICAR® to improve heart function will be studied.
The American Heart Association (AHA) 2006 update on heart disease reported that 5 million
Americans are believed to have symptomatic heart failure (HF), and 550,000 patients are
newly diagnosed each year. The estimated direct and indirect cost of HF in the United States
(U.S.) for 2006 will be ~$29.6 billion. Heart failure is a disabling chronic disease and the
most frequent discharge diagnosis for hospitalization among older adults. Despite the
significant resources expended on the treatment of this disease, outcomes remain poor. The
five-year survival for individuals diagnosed with heart failure is less than 50%, and in
end-stage heart failure, the one-year survival may be as low as 25% regardless of medical
therapy.
Recent studies suggest that the failing heart is not refractory to treatment, as was
previously believed. For example, the observation that a small percentage of subjects with
left ventricular assist devices (LVADs) can be permanently weaned from their device strongly
suggests that damaged hearts are capable of recovering lost function.
Clinical studies of MYDICAR® have not yet been conducted in humans. Celladon Corporation
(Celladon) proposes to investigate gene transfer as a method to restore SERCA2a function in
heart failure (HF) patients using a recombinant adeno-associated viral vector (AAV), which
consists of an AAV serotype 1 capsid and contains the human SERCA2a complementary DNA (cDNA)
flanked by Inverted Terminal Repeats (ITR) derived from AAV serotype 2 (AAV1/SERCA2a).
MYDICAR® refers to AAV1/SERCA2a drug product intended for administration by percutaneous
delivery.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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