N/A
Completed N=10
Endothelin Blockade in Patients With Single Ventricle Physiology
Source: ClinicalTrials.gov NCT00989911 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months — 3.3; 4.4 L/min — p=0.03
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.
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 |
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
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. Informational only — not medical advice.