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Sponsored by: |
Celladon Corporation |
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Information provided by: | Celladon Corporation |
ClinicalTrials.gov Identifier: | NCT00454818 |
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.
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Genetic: MYDICAR® Procedure: Placebo Infusion |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2 Trial of Intracoronary Administration of MYDICAR® (AAV1/SERCA2a) in Subjects With Heart Failure Divided Into Two Stages |
Estimated Enrollment: | 46 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
MYDICAR® Dose 1
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Genetic: MYDICAR®
1.4x10e11 DRP, 6x10e11 DRP, 3x10e12 DRP, or 1x10e13 DRP; antegrade epicardial coronary artery infusion
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2: Experimental
MYDICAR® Dose 2
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Genetic: MYDICAR®
1.4x10e11 DRP, 6x10e11 DRP, 3x10e12 DRP, or 1x10e13 DRP; antegrade epicardial coronary artery infusion
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3: Experimental
MYDICAR® Dose 3
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Genetic: MYDICAR®
1.4x10e11 DRP, 6x10e11 DRP, 3x10e12 DRP, or 1x10e13 DRP; antegrade epicardial coronary artery infusion
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4: Experimental
MYDICAR® Dose 4
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Genetic: MYDICAR®
1.4x10e11 DRP, 6x10e11 DRP, 3x10e12 DRP, or 1x10e13 DRP; antegrade epicardial coronary artery infusion
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5: Placebo Comparator
Placebo
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Procedure: Placebo Infusion
Saline; epicardial coronary artery infusion
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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 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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
San Diego Cardiac Center | |
San Diego, California, United States, 92123 | |
University of California at San Diego Medical Center | |
San Diego, California, United States, 92103 | |
United States, Florida | |
Shands Hospital at University of Florida | |
Gainesville, Florida, United States, 32608 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Missouri | |
Mid America Heart Institute, Saint Luke's Hospital | |
Kansas City, Missouri, United States, 64111 | |
St. Louis University Hospital | |
St. Louis, Missouri, United States, 63110 | |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | |
Newark, New Jersey, United States, 07101 | |
United States, New York | |
Columbia University Hospital | |
New York, New York, United States, 10032 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
United States, North Carolina | |
Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
University of Pittsburgh Medical Center, Presbyterian-Shadyside Hospital | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Tennessee | |
Tennessee Center for Clinical Trials & Harton Regional Medical Center | |
Tullahoma, Tennessee, United States, 37388 | |
United States, Texas | |
Cardiopulmonary Research Science and Technology Institute, Medical City Dallas Hospital | |
Dallas, Texas, United States, 75230 | |
Methodist Hospital | |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Intermountain Medical Center | |
Murray, Utah, United States, 84157 | |
United States, Wisconsin | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792 |
Principal Investigator: | Brian Jaski, MD | San Diego Cardiac Center |
Principal Investigator: | Donna Mancini, MD | Columbia University Hospital |
Principal Investigator: | Randall Starling, MD | The Cleveland Clinic |
Study Chair: | Mariell Jessup, MD | University of Pennsylvania |
Principal Investigator: | Thomas Cappola, MD, ScM | University of Pennsylvania |
Principal Investigator: | Daniel Pauly, MD | Shands Hospital, University of Florida at Gainesville |
Principal Investigator: | Barry London, MD | University of Pittsburgh |
Principal Investigator: | Barry Greenberg, MD | University of California at San Diego Medical Center |
Principal Investigator: | A. G. Kfoury, MD | Intermountain Medical Center |
Principal Investigator: | Stephen Archer, MD | University of Chicago |
Principal Investigator: | Andrew Kao, MD | Mid America Heart Institute, Saint Luke's Hospital |
Principal Investigator: | Paul J. Hauptman, MD | St. Louis University Hospital |
Principal Investigator: | Jill Kalman, MD | Mount Sinai School of Medicine |
Principal Investigator: | Douglas W. Losordo, MD | Northwestern University |
Principal Investigator: | Eric J. Eichhorn, MD, FACC | Cardiopulmonary Research Science and Technology Institutte, Medical City Dallas Hospital |
Principal Investigator: | Stephanie H. Dunlap, DO | University of Cincinnati |
Principal Investigator: | Vinay Thohan, MD | Wake Forest University |
Principal Investigator: | Maryl R. Johnson, MD | University of Wisconsin, Madison |
Principal Investigator: | Mark Dunlap, MD | MetroHealth Medical Center |
Principal Investigator: | Joaquin E. Cigarroa, MD | Oregon Health and Science University |
Principal Investigator: | Dinesh K. Gupta, MD | Tennessee Center for Clinical Trials, Harton Regional Medical Center |
Principal Investigator: | Marc Klapholz, MD | University of Medicine and Dentistry New Jersey |
Principal Investigator: | Guillermo Torre, MD | The Methodist Hospital System |
Responsible Party: | Celladon ( Jeffrey Rudy ) |
Study ID Numbers: | CELL-001, The CUPID Trial |
Study First Received: | March 30, 2007 |
Last Updated: | September 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00454818 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |