Efficacy and Safety Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2012

Conditions
Heart Failure, CongestiveDilated Cardiomyopathy
Interventions
GENETIC

MYDICAR Phase 1 (Open-label, Serial Dose-Escalation Study)

MYDICAR administered by antegrade epicardial coronary artery infusion

PROCEDURE

Placebo Infusion

Saline; epicardial coronary artery infusion

GENETIC

MYDICAR Phase 2 (Placebo-controlled, Randomized Study)

MYDICAR administered by antegrade epicardial coronary artery infusion

Trial Locations (22)

10029

Mount Sinai Medical Center, New York

10032

Columbia University Hospital, New York

15213

University of Pittsburgh Medical Center, Presbyterian-Shadyside Hospital, Pittsburgh

19104

Hospital of the University of Pennsylvania, Philadelphia

27157

Wake Forest University, Winston-Salem

32608

Shands Hospital at University of Florida, Gainesville

37388

Tennessee Center for Clinical Trials & Harton Regional Medical Center, Tullahoma

44109

MetroHealth Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

45267

University of Cincinnati, Cincinnati

53792

University of Wisconsin, Madison

60611

Northwestern University, Chicago

60637

University of Chicago Medical Center, Chicago

63110

St. Louis University Hospital, St Louis

64111

Mid America Heart Institute, Saint Luke's Hospital, Kansas City

75230

Cardiopulmonary Research Science and Technology Institute, Medical City Dallas Hospital, Dallas

77030

Methodist Hospital, Houston

84157

Intermountain Medical Center, Murray

92103

University of California at San Diego Medical Center, San Diego

92123

San Diego Cardiac Center, San Diego

97239

Oregon Health and Science University, Portland

07101

University of Medicine and Dentistry of New Jersey, Newark

Sponsors
All Listed Sponsors
lead

Celladon Corporation

INDUSTRY