Bosentan and Pulmonary Endothelial Function

Prof David S Celermajer8 enrolled

Overview

6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

BosentanDRUG

62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Acetylcholine Vascular Reactivity Response

Percent pulmonary flow change from baseline after acetylcholine

Time frame: Baseline and 6 months

Secondary Outcomes

Intravascular Ultrasound - Pulmonary Artery Wall Thickness

Change in intima-media thickness

Time frame: baseline and 6 months

Data from ClinicalTrials.gov

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