Bosentan and Pulmonary Endothelial Function
- Registration Number
- NCT01721564
- Lead Sponsor
- Prof David S Celermajer
- Brief Summary
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bosentan Bosentan 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
- Primary Outcome Measures
Name Time Method Acetylcholine Vascular Reactivity Response Baseline and 6 months Percent pulmonary flow change from baseline after acetylcholine
- Secondary Outcome Measures
Name Time Method Intravascular Ultrasound - Pulmonary Artery Wall Thickness baseline and 6 months Change in intima-media thickness