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NCT01078363 · ClinicalTrials.gov registry record · NA
Angiotensin Converting Enzyme (ACE) Inhibition and Cardiac Allograft Vasculopathy
A NA study of Cardiac Allograft Vasculopathy, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 96
- Enrollment target
- 2
- Study locations
NCT01078363: Completed NA study of Cardiac Allograft Vasculopathy, sponsored by Stanford University.
NCT01078363 is a NA study of Cardiac Allograft Vasculopathy that has completed, run by Stanford University. The registered enrollment target is 96 participants, roughly in line with the 99-participant average among 3 other Cardiac Allograft Vasculopathy trials with a reported enrollment target. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078363, a NA study of Cardiac Allograft Vasculopathy, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
also called transplant coronary artery disease or cardiac transplant vasculopathy defined as coronary artery stenosis(narrowing) ranging from 30 to 70 percent by coronary angiography. Measured in this study as change in IVUS-assessed Plaque Volume from baseline to one year.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ramipril
Study Locations (2)
California
- VA Palo Alto Health Care System - Palo Alto
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01078363 record still lists
NCT01078363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, roughly in line with the 99-participant average among 3 other Cardiac Allograft Vasculopathy trials with a reported enrollment target.
The record links to 1 condition, with Cardiac Allograft Vasculopathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01078363 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01078363 about?
NCT01078363 is a clinical study titled "Angiotensin Converting Enzyme (ACE) Inhibition and Cardiac Allograft Vasculopathy". 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 recipie...
What is the current status of trial NCT01078363?
This trial is currently completed. It is a NA study. The enrollment target is 96 participants. The study started on 2009-06. Estimated completion is 2015-04.
What conditions does trial NCT01078363 study?
This clinical trial studies the following conditions: Cardiac Allograft Vasculopathy.
What interventions are being tested in trial NCT01078363?
The interventions under investigation include: Placebo (DRUG), ramipril (DRUG).
Who is sponsoring clinical trial NCT01078363?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01078363 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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