A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease
Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension, Pulmonary; Connective Tissue Disease
Intervention: bosentan (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Hamilton Health Sciences Corporation Official(s) and/or principal investigator(s): Christine Bradley, Principal Investigator, Affiliation: Hamilton Health Sciences Corporation
Overall contact: Christine Bradley, MD, Phone: 905-546-9993, Email: mkenney@bellnet.ca
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.
Clinical Details
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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Christine Bradley, MD, Phone: 905-546-9993, Email: mkenney@bellnet.ca
Victoria Medical Center, Hamilton, Ontario L8L 5G4, Canada; Not yet recruiting Christine Bradley, MD, Principal Investigator
Additional Information
Starting date: April 2009
Last updated: March 17, 2009
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