Bosentan and Pulmonary Endothelial Function

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

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Key information

Conditions

Pulmonary Arterial Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

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

Primary outcomes

Acetylcholine Vascular Reactivity Response

Time frame: Baseline and 6 months

Percent pulmonary flow change from baseline after acetylcholine

Secondary outcomes

Intravascular Ultrasound - Pulmonary Artery Wall Thickness

Time frame: baseline and 6 months

Change in intima-media thickness

Sponsors and collaborators

Lead sponsor

Prof David S Celermajer

Other

Registry information

Official study title

Pulmonary Artery Remodelling With Bosentan

Acronym: PARBO

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Nov 5, 2012
Registry last updated: Oct 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed