Bosentan and Pulmonary Endothelial Function

Pulmonary Arterial Hypertension Clinical Trial

— PARBO  

Official title:

Pulmonary Artery Remodelling With Bosentan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721564
• Other study ID #: X05-0255
• Status: Completed
• Phase: N/A
• First received: November 1, 2012
• Last updated: October 18, 2016
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: October 2016
• Source: Royal Prince Alfred Hospital, Sydney, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof David S Celermajer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetylcholine Vascular Reactivity Response	Percent pulmonary flow change from baseline after acetylcholine	Baseline and 6 months	No
Secondary	Intravascular Ultrasound - Pulmonary Artery Wall Thickness	Change in intima-media thickness	baseline and 6 months	No