Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 7/1/2018 |
| Start Date: | May 2011 |
| End Date: | December 2012 |
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 blood levels of aliskiren and determine if aliskiren alters the blood
levels of the anti-rejection medication, cyclosporine, in these patients. In terms of
efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart
transplant patients.
medication, aliskiren, in heart transplant patients. In terms of safety, the investigators
will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood
levels of the anti-rejection medication, cyclosporine, in these patients. In terms of
efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart
transplant patients.
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 of cyclosporine, chronic kidney disease, and denervation. Hypertension in
this population is difficult to treat, and most patients require therapy with multiple
antihypertensive agents in order to achieve adequate blood pressure control. Aliskiren, a
direct renin inhibitor, is a novel antihypertensive agent with a unique mechanism of action
and potent blood pressure-lowering effects. As such, aliskiren is an attractive treatment
option for post-cardiac transplant hypertension. This study will characterize the
pharmacokinetic drug-drug interaction profile, pharmacodynamics, and safety of aliskiren 75
mg daily (low-dose) and 150 mg daily, when given in combination with cyclosporine, in cardiac
transplant patients.
93% at 5 years post-transplant. Post-cardiac transplant hypertension is due to multiple
factors such as use of cyclosporine, chronic kidney disease, and denervation. Hypertension in
this population is difficult to treat, and most patients require therapy with multiple
antihypertensive agents in order to achieve adequate blood pressure control. Aliskiren, a
direct renin inhibitor, is a novel antihypertensive agent with a unique mechanism of action
and potent blood pressure-lowering effects. As such, aliskiren is an attractive treatment
option for post-cardiac transplant hypertension. This study will characterize the
pharmacokinetic drug-drug interaction profile, pharmacodynamics, and safety of aliskiren 75
mg daily (low-dose) and 150 mg daily, when given in combination with cyclosporine, in cardiac
transplant patients.
Inclusion Criteria:
- 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 Criteria:
- 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.
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