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Clinical Trials/NCT01721564
NCT01721564CompletedNot Applicable

Pulmonary Artery Remodelling With Bosentan

Prof David S Celermajer0 sites8 target enrollmentStarted: April 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
8
Primary Endpoint
Acetylcholine Vascular Reactivity Response
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Bosentan

Experimental

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

Intervention: Bosentan (Drug)

Outcomes

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(baseline and 6 months)

Investigators

Sponsor
Prof David S Celermajer
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Prof David S Celermajer

Scandrett Professor of Cardiology

Royal Prince Alfred Hospital, Sydney, Australia

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