Ambrisentan in Single Ventricle

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypoplastic Left Heart Syndrome, Hypoplastic Right-sided Heart Complex

In brief

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.

Key facts

Study ID

NCT02080637

Run by

Kevin Hill

People needed

16

Starts

2015-07-01

Expected to finish

2017-08-20

Last updated by the study team

2019-09-12

Who can join

Age: 2 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 24 months; ≤120 months.
• History of congenital heart disease with severe hypoplasia of a right or left ventricle.
• Undergoing Fontan surgery as part of standard clinical care.
• Availability and willingness of the parent/legally authorized representative to provide written informed consent and, as appropriate, assent from the child.

You may not qualify if…

• History of serious adverse event related to ambrisentan administration.
• History of ambrisentan exposure within 48 hours of the study.
• Presence of pulmonary venous obstruction.
• Treatment with cyclosporin.
• Any of the following - as determined by the attending physician
• Significant hemodynamic instability
• Sepsis.
• Need for ECMO support.
• Renal failure defined as serum creatinine > 2 times higher than the upper limit of normal.
• Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase > 3 times higher than the upper limit of normal.
• Thrombocytopenia defined as a platelet count < 50 000 cells/µL.
• Leukopenia defined as white blood cells < 2500 cells/µL.
• Anemia defined as hemoglobin < 8mg/dL.
• Atrial hypertension (mean LA pressure > 12mm Hg).

Where it is running

• Duke Universtiy Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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