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A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

Primary Purpose

Hypertension, Pulmonary, Connective Tissue Disease

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
bosentan
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women ≥ 18 years of age

  • For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception:

    • Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended.
    • Intrauterine devices (IUDs)
    • Oral contraceptives, if used in combination with a barrier method
  • Body weight of 40 kg or higher
  • Patients diagnosed with connective tissue disease

  • Hemodynamics at rest, based on cardiac catheterization, should be as follows:

    • Mean pulmonary arterial pressure (mPAP) : 18 - 25 mmHg
    • PCWP ≤ 15 mmHg
  • Hemodynamics during exercise, based on cardiac catheterization, should be as follows: mPAP > 30 mmHg
  • Provide written informed consent

Exclusion Criteria:

  • PAH associated with any other condition
  • Severe obstructive lung disease : FEV1∕ FVC <0.5
  • Total lung capacity <60% of normal predicted value
  • Unable or unwilling have a cardiac catheterization procedure
  • Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (6-MWT)
  • Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
  • Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
  • AST and ∕or ALT > 3 times uln
  • Hemoglobin concentration > 25% below the lower limit of normal
  • Systolic blood pressure < 85 mm Hg
  • Pregnancy or breast-feeding
  • Treatment or planned treatment with another investigational drug
  • Treatment with an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion
  • Treatment with calcineurin-inhibitors (i.e., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of study start;
  • Known hypersensitivity to bosentan or any of the excipients

Sites / Locations

  • Victoria Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bosentan

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome is the change in the following hemodynamics during exercise: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output∕cardiac input (CO∕CI), mean right arterial pressure (mRAP)

Secondary Outcome Measures

Change in hemodynamics at rest: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output/cardiac input (CO∕CI), mean right arterial pressure (mRAP)

Full Information

First Posted
March 17, 2009
Last Updated
March 17, 2009
Sponsor
Hamilton Health Sciences Corporation
Collaborators
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00864201
Brief Title
A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
Official Title
A Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
Actelion

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objectives of this exploratory study are to evaluate the effects of bosentan on hemodynamics (via cardiac catheterization) during exercise in patients with Pulmonary Arterial Hypertension (PAH) who have abnormal hemodynamics during exercise but normal hemodynamics at rest. The authors hypothesize that early treatment may change the course of disease progression by improving hemodynamics during exercise, thus delaying disease progression.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bosentan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bosentan
Intervention Description
bosentan 62mg bid x 4 weeks, followed by bosentan 125mg bid x 20 weeks
Primary Outcome Measure Information:
Title
The primary outcome is the change in the following hemodynamics during exercise: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output∕cardiac input (CO∕CI), mean right arterial pressure (mRAP)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in hemodynamics at rest: pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), cardiac output/cardiac input (CO∕CI), mean right arterial pressure (mRAP)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women ≥ 18 years of age For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception: Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended. Intrauterine devices (IUDs) Oral contraceptives, if used in combination with a barrier method Body weight of 40 kg or higher Patients diagnosed with connective tissue disease Hemodynamics at rest, based on cardiac catheterization, should be as follows: Mean pulmonary arterial pressure (mPAP) : 18 - 25 mmHg PCWP ≤ 15 mmHg Hemodynamics during exercise, based on cardiac catheterization, should be as follows: mPAP > 30 mmHg Provide written informed consent Exclusion Criteria: PAH associated with any other condition Severe obstructive lung disease : FEV1∕ FVC <0.5 Total lung capacity <60% of normal predicted value Unable or unwilling have a cardiac catheterization procedure Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (6-MWT) Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C AST and ∕or ALT > 3 times uln Hemoglobin concentration > 25% below the lower limit of normal Systolic blood pressure < 85 mm Hg Pregnancy or breast-feeding Treatment or planned treatment with another investigational drug Treatment with an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion Treatment with calcineurin-inhibitors (i.e., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of study start; Known hypersensitivity to bosentan or any of the excipients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Bradley, MD
Phone
905-546-9993
Email
mkenney@bellnet.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Bradley
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Medical Center
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G4
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Bradley, MD

12. IPD Sharing Statement

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A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

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