The Effects of Ambrisentan on Exercise Capacity in Fontan Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01971580|
Recruitment Status : Completed
First Posted : October 29, 2013
Results First Posted : May 7, 2018
Last Update Posted : May 7, 2018
Patients with a Fontan type palliation are limited by preload, or the rate at which blood returns to the heart after passively traversing the pulmonary capillary bed. By decreasing pulmonary vascular resistance using an endothelin receptor antagonist, both ventricular filling pressures and volumes will increase with a simultaneous decrease in systemic impedance to flow and decrease in central venous pressures, leading to an improved capacity to increase cardiac output, and thereby an improvement in patient functional status.
Patients who are candidates for the study will be randomized to a double-blind single crossover study. Therapy with either ambrisentan or placebo will be continued for 12 weeks, with a 2 week washout period between treatment periods. Subjects will be subjected to a VO2 max test to evaluate exercise capacity at enrolment, and on the last day of each treatment period. As a component of the VO2 max testing the patient's VE, VCO2, VE/VCO2 slope, ventilatory anaerobic threshold (VAT), peak work, efficiency, and other physiologic parameters as typically obtained from cardiopulmonary testing will be assessed. In addition, each patient will be asked to complete an SF-36 quality of life questionnaire at enrollment, and on the last day of each study period.
|Condition or disease||Intervention/treatment||Phase|
|Single Ventricle Fontan Palliation||Drug: Ambrisentan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Ambrisentan on Exercise Capacity in Fontan Patients|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Ambrisentan first, Placebo second
These patients will be randomized to have ambrisentan during the first study period, and placebo during the second study period.
Other Name: Letaris
Placebo first, Ambrisentan second
These patients will be randomized to have placebo during the first study period, and ambrisentan during the second study period.
Other Name: Letaris
- Change in VO2 Max [ Time Frame: Baseline compared to 12 weeks therapy with either ambrisentan or placebo ]
- Quality of Life [ Time Frame: 12 weeks ]Change in Rand 36-item Short Form (SF-36) physical function score (0-100). On the Rand SF-36 questionnaire, a score closer to 100 (higher) suggests lesser disability, while a score closer to 0 (lower) suggests more disability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971580
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|