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Bosentan and Pulmonary Endothelial Function (PARBO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof David S Celermajer, Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier:
NCT01721564
First received: November 1, 2012
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Pulmonary Arterial Hypertension
 Drug: Bosentan

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulmonary Artery Remodelling With Bosentan

Resource links provided by NLM:

Drug Information available for: Bosentan
U.S. FDA Resources

Further study details as provided by Royal Prince Alfred Hospital, Sydney, Australia:

Primary Outcome Measures:
  • Acetylcholine Vascular Reactivity Response [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Percent pulmonary flow change from baseline after acetylcholine


Secondary Outcome Measures:
  • Intravascular Ultrasound - Pulmonary Artery Wall Thickness [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Change in intima-media thickness


Enrollment: 8
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bosentan
62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
 Drug: Bosentan
62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721564

Sponsors and Collaborators
Prof David S Celermajer
Investigators
Principal Investigator: David S Celermajer, MBBS, PhD, DSc Royal Prince Alfred Hospital, Sydney, Australia
  More Information

No publications provided

Responsible Party: Prof David S Celermajer, Scandrett Professor of Cardiology, Royal Prince Alfred Hospital, Sydney, Australia
ClinicalTrials.gov Identifier: NCT01721564     History of Changes
Other Study ID Numbers: NCT00595049
Study First Received: November 1, 2012
Results First Received: December 4, 2012
Last Updated: January 21, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013