Status:
COMPLETED
First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Actelion
Conditions:
Hypertension, Pulmonary
Eligibility:
All Genders
18-85 years
Brief Summary
The purpose of this study is to evaluate the strategy of initiating double oral combination therapy with bosentan and sildenafil at the time of diagnosis of pulmonary arterial hypertension (PAH) in a ...
Detailed Description
Current treatment paradigms for PAH suggest adopting goals of therapy with relatively objective parameters such as 6 minute walk distance to determine when to add a second oral agent (1). This often e...
Eligibility Criteria
Inclusion
- Patients with symptomatic Functional Class III PAH in the following categories: Idiopathic (IPAH), Familial (FPAH), Associated with connective tissue disease, Associated with drugs or toxins
- PAH diagnosed by right heart catheterization, defined as: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, PVR \> 3 mmHg/l/min (Wood units) or \> 240 dyn sec cm-5, pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
- Baseline 6 MWT distance \> 150 and \< 450 m
Exclusion
- Treatment with ERAs other than bosentan;
- Treatment with PDE5 inhibitors other than sildenafil;
- Treatment with any prostanoid;
- PAH associated with thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy; valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization
- Restrictive lung disease: total lung capacity (TLC) \< 60% of normal predicted value;
- Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) \< 50%
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01247116
Start Date
December 1 2009
End Date
December 1 2015
Last Update
June 12 2018
Active Locations (1)
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1
University of Calgary, Peter Lougheed Hospital
Calgary, Alberta, Canada, T1Y 6J4