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Angiotensin Converting Enzyme (ACE) Inhibition and Cardiac Allograft Vasculopathy
Not Recruiting
Trial ID: NCT01078363
Purpose
Cardiac transplantation is the ultimate treatment option for patients with end stage heart
failure.
Cardiac allograft vasculopathy remains a leading cause of morbidity and mortality after
transplantation.
Angiotensin converting enzyme inhibitors are used in less than one half of transplant
recipients. Preliminary data suggest that angiotensin converting enzyme inhibitors retard the
atherosclerotic plaque development that is the hallmark of cardiac allograft vasculopathy.
Moreover, this class of drug appears to increase circulating endothelial progenitor cell
number and has anti-inflammatory properties, both of which improve endothelial dysfunction,
the key precursor to the development of cardiac allograft vasculopathy.
The objective of this project is to investigate the role of an angiotensin converting enzyme
inhibitor, ramipril, in preventing the development of cardiac allograft vasculopathy. During
the first month after cardiac transplantation subjects will undergo coronary angiography with
intravascular ultrasound measurements of plaque volume in the left anterior descending
coronary artery. Using a coronary pressure wire, epicardial artery and microvascular
physiology will be assessed. Finally, endothelial function and mediators of endothelial
function, including circulating endothelial progenitor cells, will be measured. Subjects will
then be randomized in a double blind fashion to either ramipril or placebo. After 1 year, the
above assessment will be repeated. The primary endpoint will be the development of cardiac
allograft vasculopathy based on intravascular ultrasound-derived parameters. The second aim
will be to assess the effect of ramipril on endothelial dysfunction early after
transplantation. The final aim is to determine the impact of ramipril on coronary physiology
early after transplantation.
Official Title
ACE Inhibition and Cardiac Allograft Vasculopathy
Stanford Investigator(s)
William Fearon, MD
Professor of Medicine (Cardiovascular Medicine)
Hannah Valantine
Professor of Medicine (Cardiovascular)
Eligibility
Inclusion Criteria:
- Heart transplant recipient within the first month of transplant;
- 12 years of age or older;
- Must have a serum creatinine less than 2.0 mg/dl;
- Will provide written informed consent;
- Female patients of childbearing potential must have negative pregnancy test;
- For pediatric patient, parent(s) will provide consent and the child will sign assent.
Exclusion Criteria:
- Less than 12 years of age;
- Have more than one solid organ transplant at time of heart transplant;
- Has serum creatinine greater than 2.0 mg/dl;
- Pregnancy.
Intervention(s):
drug: ramipril
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
William Fearon
6507252621