Clinical Trials
Some of our ongoing trials include:
Familial Dilated Cardiomyopathy (FDC)
The FDC Research Project was founded by Dr. Ray Hershberger in 1993 at Oregon Health & Science University; the project moved to the University of Miami in 2007. The scientific goals of the project are to determine the molecular genetic basis of familial dilated cardiomyopathy, that is, to identify the gene or genes that cause or predispose an individual to dilated cardiomyopathy and heart failure, and to understand the phenotypic variation of genetic cardiomyopathy in individual and families. An extensive family recruitment continues. This NIH-funded research team is composed of genetic counselors, clinicians and scientists in cardiology and genetics. Novel clinical programs are emerging from this research effort. It is our hope that new insights from these studies will lead to novel strategies for the detection, screening, prevention and treatment of dilated cardiomyopathy and heart failure.
For more information, visit www.fdc.to.
Percutaneous Aortic Valve Replacement
Narrowing of the aortic valve, or "Aortic Stenosis" is a common problem. By reducing the capacity of the heart to deliver blood to the body, it can cause chest pain, heart failure, fainting, and even sudden death. Traditionally the only treatment for this disease has been with open-heart surgery, to replace the narrowed valve with a new artificial valve. However for some patients, and particularly in the elderly or those with other medical problems, a non-surgical option might have advantages. For the first time, a non-surgical approach for treating aortic stenosis has been developed, using a catheter to deliver the new artificial valve. University of Miami cardiologists Dr. William O’Neill and Dr. Alan Heldman have successfully performed this procedure in a clinical trial comparing the new valve to standard therapies.
For more information, please contact Phillip Gonzalez at 305-243-7181.
Combination Therapy in Pulmonary Arterial Hypertension COMPASS III
The University of Miami Miller School of Medicine is participating in a multicenter trial testing the benefits of Bosentan-based therapy in patients with pulmonary arterial hypertension. For this trial, which is also called COMPASS 3: An Open-Label, Multi-Center Study Employing a Targeted 6-MWT Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of MRI on Cardiac Remodeling, university investigators are recruiting symptomatic patients with WHO group I pulmonary hypertension including patients with idiopathic PAH, familial PAH and PAH associated with connective tissue disease or drugs who have never received drug therapy for their pulmonary arterial hypertension (drug naïve). Subjects will be comprehensively evaluated and intensely monitored by pulmonary arterial hypertension experts at the university. They will assigned to receive either Bosentan alone or Bosentan plus revatio (sildenafil) in those without a clinical response to Bosentan.
For more information, please contact Dr. Debra Fertel at dfertel@med.miami.edu or Dr .Howard Willens at hwillens@med.miami.edu. Physician and patient inquiries are welcome.
Additional information about the trial can also be found online at clinicaltrials.gov/ct2/show/NCT00433329?term=bosentan+and+sildenafil&rank=3.
Adult Stem Cell Therapy
UM Cardiologists are at the forefront of developing cardiac stem cell therapies. UM researchers led the first clinical trial of bone marrow cells in heart attack patients, with very promising results. Further clinical trials are being performed in conjunction with the University of Miami Interdisciplinary Stem Cell Institute (ISCI).
The University of Miami is conducting two research studies using autologous adult stem cells in patients with chronic ischemic left ventricular dysfunction. That is, these research studies will use a patient’s own stem cells (derived from the patient’s bone marrow) to evaluate their safety and effectiveness in the treatment of their poorly functioning heart. In the first study, cells are delivered to the heart at the time of coronary bypass surgery. In the second study, cells are delivered to the heart using a catheter, inserted from a tiny puncture in the leg. We are actively recruiting for the second trial. Click here for more details. In both studies, patients will be followed closely to evaluate the effect of their own stem cells on healing and recovery from heart muscle damage caused by a heart attack.
Contact Information: For further information, please call Darcy Velazquez at 305-243-9106.