Heart Transplant Clinical Trials
Cedars-Sinai Heart Institute is currently conducting the following heart transplant clinical trials:
The Assessment of Mechanism Leading to Sexual Dysfunction After Heart Transplantation, and its impact on the Quality of Life.
Principal Investigator: Ernst Schwarz, MD
IRB Approval Number: 11933
Contact: (310) 423-3851
Recruiting
Summary: Arm A: Patients who have already undergone heart transplantation
Examines the issue of sexual function in 300 cardiac patients who have undergone heart transplantation surgery at Cedars Sinai-Medical Center within the last 10 years through quality of life questionnaires that deal with patients¿ mood and attitude toward the surgery and also their activity levels. Arm A Substudy: Approximately 20 randomly drawn patients will be invited to participate in a more in-depth study. Participants will be required to take a simple blood test to evaluate other cardiovascular risk factors including blood sugar levels blood vessel damage markers, kidney function and diabetes assessment. In addition this group will undergo a BART test (Brachial Artery Reactivity Test). Arm B: 20 patients who are scheduled for cardiac transplantation surgery will be recruited. Quality of life issues regarding heart transplantation surgery including mood/attitude, activity levels, and overall out look on life will be examined.
New Noninvasive Techniques for the Assessment of Transplant Rejection: Use of Echocardiography, Magnetocardiography and Serum Markers
Principal Investigator: Kirsten Tolstrup, MD
IRB Approval Number: 8144
Contact: David Gallegos, RN (310) 423-4993
Recruiting
Summary: This study involves the use of non-invasive techniques to screen for early heart transplant rejection. These tests include an ultrasound of the heart, an echocardiogram and magnetocardiography (MCG) a safe, FDA approved, non-invasive heart scan. Study procedures also include a 12 lead electrocardiogram and blood pressure measurement. Blood tests will also be taken. Patients undergoing standard heart biopsies post heart transplant maybe enrolled.
Myfortic® in Heart Transplant Recipients
Principal Investigator: Ernst Schwarz, MD
IRB Approval Number: 9810
Contact: (310) 423-6152
Recruiting
Summary: The objective of this study is to assess the gastrointestinal (GI) tolerability of anti-rejection maintenance therapy with the study drug, Myfortic®, in heart transplant patients, and to ascertain the safety and efficacy of changing from another commonly used drug, Cellcept®, to the study drug in the management of heart transplant patients. Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of myocphenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. Patients who have undergone successful orthotopic heart transplant surgery, currently taking Cellcept® and experiencing gastrointenstinal side-effects from this standard therapy are eligible.
