Ambrisentan in Single Ventricle
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|ClinicalTrials.gov Identifier: NCT02080637|
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of ambrisentan after Fontan surgical palliation of single ventricle heart defects.
Study activities and population group: Children undergoing Fontan surgical palliation for single ventricle defects will be eligible for the study. Up to 20 subjects will be enrolled (16 ambrisentan, 4 placebo) and will receive 3 days (3 doses) of ambrisentan starting on post-operative day #1 upon returning from the operating room. Ambrisentan plasma levels will be obtained at specified time points during treatment. Post-operative monitoring lines will be used to measure effects of ambrisentan on hemodynamics and pulmonary / systemic endothelial function.
|Condition or disease||Intervention/treatment||Phase|
|Hypoplastic Left Heart Syndrome Hypoplastic Right-sided Heart Complex||Drug: Ambrisentan Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||July 20, 2017|
|Actual Study Completion Date :||August 20, 2017|
Active Comparator: Ambrisentan
Oral ambrisentan 2.5 - 5 mg, single dose, once daily
Once daily oral dosing
Other Name: Leitaris
Placebo Comparator: Placebo
Oral placebo 2.5 - 5 mg, single dose, once daily
- Area Under the Curve for Ambrisentan Plasma Concentration [ Time Frame: 0-1,1-6,18-30 and 40-60 hours ]Plasma samples collected at 0-1,1-6,18-30 and 40-60 hours after administration of the first ambrisentan dose.
- Change in Pulmonary Vascular Resistance Index [ Time Frame: baseline to 2 hours post ambrisentan administration ]Hemodynamic data, including Fontan pressures, common atrial pressures and saturations, will be collected at the specified timepoints. Pressures and saturations will be measured from existing monitoring lines. Standard Fick calculations will be used to calculate pulmonary vascular resistance (calculated as trans-pulmonary gradient [Fontan pressure - atrial pressure] / pulmonary blood flow [Qp]) and reported in Wood Units x m^2.
- Amount of Chest Tube Drainage Post Fontan Operation [ Time Frame: 0-96 hours post Fontan ]Total chest tube drainage in mL in first 96hrs after Fontan
- Duration of Chest Tube Drainage Post Fontan Operation [ Time Frame: measured for the duration of the post-operative hospitalization or for 30 days, whichever is shorter ]Chest tube duration will be calculated as the number of days from placement to removal.
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): NCT02080637
|United States, North Carolina|
|Duke Universtiy Hospital|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Kevin Hill, MD||Duke University|