Bosentan and Pulmonary Endothelial Function (PARBO)

Prof David S Celermajer

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: Bosentan

Study type: Interventional

Funder types: Other

Identifiers

NCT01721564

X05-0255

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Bosentan

Experimental group

Description:

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

Treatment:

Drug: Bosentan