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Bosentan and Pulmonary Endothelial Function (PARBO)

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bosentan
Sponsored by
Prof David S Celermajer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bosentan

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Acetylcholine Vascular Reactivity Response
    Percent pulmonary flow change from baseline after acetylcholine

    Secondary Outcome Measures

    Intravascular Ultrasound - Pulmonary Artery Wall Thickness
    Change in intima-media thickness

    Full Information

    First Posted
    November 1, 2012
    Last Updated
    October 18, 2016
    Sponsor
    Prof David S Celermajer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01721564
    Brief Title
    Bosentan and Pulmonary Endothelial Function
    Acronym
    PARBO
    Official Title
    Pulmonary Artery Remodelling With Bosentan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    December 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Prof David S Celermajer

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Arterial Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bosentan
    Arm Type
    Experimental
    Arm Description
    62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
    Intervention Type
    Drug
    Intervention Name(s)
    Bosentan
    Intervention Description
    62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
    Primary Outcome Measure Information:
    Title
    Acetylcholine Vascular Reactivity Response
    Description
    Percent pulmonary flow change from baseline after acetylcholine
    Time Frame
    Baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    Intravascular Ultrasound - Pulmonary Artery Wall Thickness
    Description
    Change in intima-media thickness
    Time Frame
    baseline and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David S Celermajer, MBBS, PhD, DSc
    Organizational Affiliation
    Royal Prince Alfred Hospital, Sydney, Australia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Bosentan and Pulmonary Endothelial Function

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