N/A
N=8
Bosentan and Pulmonary Endothelial Function
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01721564 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Acetylcholine Vascular Reactivity Response — 180 percentage of baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bosentan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prof David S Celermajer
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acetylcholine Vascular Reactivity Response |
180 | — |
| SECONDARY Intravascular Ultrasound - Pulmonary Artery Wall Thickness |
34 | — |
Summary
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
Eligibility Criteria
Inclusion Criteria
- Pulmonary arterial hypertension; idiopathic and connective tissue disease associated
- Confirmed or invasive haemodynamic:
- Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury
- Pulmonary capillary wedge pressure less than 15 millimeters of mercury
- No prior pulmonary hypertension specific therapy
- Ability to provide informed consent
Exclusion Criteria
- Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine
- Advanced renal disease
- Previous allergic reaction to contrast agents
Data sourced from ClinicalTrials.gov (NCT01721564). 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.