First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
1 other identifier
observational
12
1 country
1
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 preliminary way.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 12, 2018
June 1, 2018
6 years
November 23, 2010
June 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
6 minute walk test distance
4 months
Secondary Outcomes (4)
6 minute walk test distance
12 months
Echocardiographic parameters
4 months
Hemodynamics
4 months
Quality of Life as measured by CAMPHOR questionnaire
4 months
Eligibility Criteria
Consecutive patients with idiopathic pulmonary arterial hypertension (IPAH) or PAH associated with connective tissue disease that are naive to PAH targeted therapies will be enrolled.
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Actelioncollaborator
Study Sites (1)
University of Calgary, Peter Lougheed Hospital
Calgary, Alberta, T1Y 6J4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naushad Hirani, MD
University of Calgary
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Assistant Professor
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 24, 2010
Study Start
December 1, 2009
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
June 12, 2018
Record last verified: 2018-06