Translating Medical Advances into Patient Care
Stanford Hospital's physicians are faculty members at the Stanford School of Medicine, where they are at the forefront of the research that leads to ground-breaking treatments for patients. Stanford clinicians are scientists who regularly contribute to major advancements in their fields. The following research papers have been published by members of Stanford's Heart Transplant Team.
- Universal noninvasive detection of solid organ transplant rejection.,
Snyder TM et al. - Gene-expression profiling for rejection surveillance after cardiac transplantation., Pham MX et al.
- Effect of rapamycin therapy on coronary artery physiology early after cardiac transplantation., Sinha SS et al.
- Right ventricular dysfunction predicts poor outcome following hemodynamically compromising rejection., Haddad F et al.
- Cytomegalovirus-associated allograft rejection in heart transplant patients., Potena et al.
Clinical Research Studies
Clinical research studies are designed to answer specific questions, sometimes about a new drug or medical device's safety and effectiveness. Research studies may be observational studies or clinical trials. Observational studies are those in which information is collected from patients in order to better understand specific conditions (for example, what factors are associated with long-term survival after a heart transplant?) or to develop new tests that can detect rejection or other heart transplant complications in their early stages. Clinical trials are research studies in which patients are assigned, by chance, to a new medication or to placebo (typically a pill or liquid that looks like the study medication but does not have any medicines in it). Clinical trials are done to determine if new treatments are safe and effective in preventing or treating heart transplant complications.
Clinical research studies are done in close collaboration with scientists and physicians from many areas of expertise across Stanford University. To ensure the highest ethical standards are maintained, the Institutional Review Board (IRB) is responsible for oversight of all studies. You can find information about current clinical trials on the Stanford University Clinical Trial Directory site or at ClinicalTrials.gov.
Below are clinical research studies specifically related to heart transplantation that are currently being conducted at Stanford. Please be aware that studies often have extensive criteria that must be met before enrollment, and you may not be eligible for a given study.
Please feel free to discuss these studies with any member of the Heart Transplant team or contact the Heart Transplant Research Nurse Coordinator, Helen Luikart [luikart], RN, MS, at 650 -724-2883.
Clinical Studies in Heart Transplantation
- ACE Inhibition and Cardiac Allograft Vasculopathy
Funded by the National Institutes of Health, this is a clinical trial examining a novel therapy to prevent chronic rejection (graft coronary artery disease) after heart transplantation. We hope to learn more about the role of a class of medications called angiotensin converting enzyme (ACE) inhibitors in the development of cardiac allograft vasculopathy, a common condition in which the donor coronary arteries develop diffuse narrowing and blockages. This is the leading cause of long-term graft loss after heart transplantation. The study should show whether ACE inhibitors slow down the progression of coronary artery disease in the new heart after transplantation. This study is open to adults and children over the age of 12 years, immediately after heart transplantation. - Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy after Heart Transplantation
Funded by the American Heart Association, this clinical trial is testing whether the drug pioglitazone can prevent the development or progression of cardiac allograft vasculopathy (CAV--a form of chronic rejection) after heart transplantation. We hope to learn whether pioglitazone can effectively prevent the "thickening" or "narrowing" of the donor coronary arteries that commonly occurs after heart transplantation. This study is open for recipients who are within one to four years after heart transplantation and who do not have diabetes. - Genomic Transplant Dynamics (GTD)
Funded by the National Institutes of Health, this observational study proposes to develop a non-invasive method to diagnose acute rejection after heart transplantation. We hope to learn whether the transplant donor's DNA can be detected in the blood of heart transplant recipients during episodes of acute rejection. The study is open to all adult and pediatric heart and lung transplant patients before and immediately after transplantation. - Clinical and Genetic Evaluation of Donors for Cardiac Transplantation (GED)
Funded by the National Institutes of Health, this is an observational study examining the relationship between donor characteristics and recipient outcomes after heart transplantation. We hope to learn whether clinical and genetic features of a heart transplant donor have an effect on outcomes after transplantation, including graft (donor heart) function, development of rejection, and survival. This study is open to adult heart transplant recipients during the first year after transplantation. - Heartsbreath
Funded by the National Institutes of Health, this is an observational study of a non-invasive method to diagnose acute rejection after heart transplantation. We hope to learn whether measurement of organic compounds in your breath can be used to detect acute rejection. This study is open to adults in the first year after heart transplant. - Determinants of Long Term Survival
Funded by a grant from the Stiftung Charite Foundation, a non-profit in Germany, participants of this observational study will be enrolled at Stanford as well as at a collaborating site, the German Heart Institute in Berlin. We hope to learn about distinguishing features of patients who survived for an extended period after heart transplantation. This research study is open to those who received heart transplants at Stanford Hospital, and who have survived more than 15 years after the transplant surgery. - Cardiac Magnetic Resonance Imaging as a Non-Invasive Tool for Diagnosis of Complications After Heart Transplantation
Funded by investigator funds, the purpose of this observational study is to provide comprehensive Cardiac MRI evaluation of heart transplant recipients. Participants will be followed for approximately one year to determine whether CMR findings predict future cardiovascular events. The study is open to all heart transplant recipients who are able to undergo cardiac MRI. If you have any questions about this study, please contact Marie-Claude Parent, MD; or Phillip Yang, MD. Contact phone number: 650-714-3272 or 650-498-8008.
VAD Clinical Trials
- HeartWare Ventricular Assist System Continued Access Protocol
Funded by HeartWare, Inc., this is a continuation of a clinical trial involving the HeartWare Ventricular Assist System which was performed at 30 centers. The purpose of this study is to evaluate the safety and effectiveness of the HeartWare ventricular assist system in patients listed for heart transplant who have refractory, advanced heart failure and who are at risk of death. The original trial concluded in August 2010, but patients are still able to undergo implantation of the HeartWare ventricular assist system under a Continued Access Protocol approved by the U.S. Food and Drug Administration. Participants in this study are followed closely until they receive their heart transplant and then annually for five years. If you have questions about this study, please contact the Principal Investigators Philip Oyer, MD or Hari Mallidi, MD at 650-723-5771.
