Bosentan and Pulmonary Endothelial Function

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Bosentan

• 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

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-05
• Study Completion: 2009-12
• Study First Submitted: 2012-11-01
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Results First Submitted: 2012-12-04
• Results First Submitted QC: 2013-01-21
• Results First Posted: 2013-02-25
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

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