N/A N=10 Supportive Care

Endothelin Blockade in Patients With Single Ventricle Physiology

Congenital Heart Disease

Bottom Line

View on ClinicalTrials.gov: NCT00989911 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months — 3.3; 4.4 L/min — p=0.03

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bosentan (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months	3.3; 4.4	0.03 sig

Summary

Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.

Eligibility Criteria

Inclusion Criteria

At least 12 years of age
Single ventricle congenital heart disease
Require cardiac magnetic resonance imaging (MRI) for clinical purposes.

Exclusion Criteria

3 times upper limit of normal)
Contraindications to MRI (including pacemakers)
Use of Bosentan within one month prior to enrollment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00989911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.