Status:
TERMINATED
Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
American Heart Association
Conditions:
Hypertension
Cardiac Transplantation
Eligibility:
All Genders
21-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the bloo...
Detailed Description
Hypertension is a major complication following cardiac transplantation, with a prevalence of 93% at 5 years post-transplant. Post-cardiac transplant hypertension is due to multiple factors such as use...
Eligibility Criteria
Inclusion
- 6 months or more since cardiac transplant
- Clinically stable from a transplant perspective
- Maintained on a stable immunosuppressant regimen containing cyclosporine + an antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid
- Hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm Hg and a seated average diastolic blood pressure of ≥ 90 mm Hg, based on 3 separate measurements, spaced 2 minutes apart.
Exclusion
- Clinical instability from a cardiac transplant perspective
- Contraindications to aliskiren therapy
- Conditions that may increase the risk of aliskiren adverse effects
- Severe hypertension
- Concomitant medications known to increase or decrease aliskiren plasma exposure.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01235910
Start Date
May 1 2011
End Date
December 1 2012
Last Update
June 29 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Denver
Aurora, Colorado, United States, 80045