Trial | NCT01721564  Report issue

Title

Bosentan and Pulmonary Endothelial Function
Pulmonary Artery Remodelling With Bosentan

  • Phase

    N/A

  • Study Type

    Interventional

  • Intervention/Treatment

    bosentan ...

  • Study Participants

    8
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.
Study Started
Apr 30
2006
Primary Completion
May 31
2009
Study Completion
Dec 31
2009
Results Posted
Feb 25
2013
Estimate
Last Update
Oct 19
2016
Estimate

Drug Bosentan

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

Bosentan Experimental

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

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

Summary

Bosentan

All Events

Event Type Organ System Event Term

Acetylcholine Vascular Reactivity Response

Percent pulmonary flow change from baseline after acetylcholine

Bosentan

180.0
percentage of baseline (Mean)
Standard Deviation: 20

Intravascular Ultrasound - Pulmonary Artery Wall Thickness

Change in intima-media thickness

Bosentan

34.0
percentage of baseline (Mean)
Standard Deviation: 2

Age, Continuous

66
years (Mean)
Standard Deviation: 4

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Bosentan