First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study|
- 6 minute walk test distance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- 6 minute walk test distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Echocardiographic parameters [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Hemodynamics [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Quality of Life as measured by CAMPHOR questionnaire [ Time Frame: 4 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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 entails observing deterioration in the patient on a single agent before instituting the second one. This strategy could be problematic, as patients may never recover the function lost due to progressive PAH (2). In addition, given the malignant nature of the clinical course of PAH in many cases and the nature of the underlying proliferative vasculopathy, some have argued that altering this paradigm to resemble that used in cancer chemotherapy may be more appropriate (3). That is, "induction" therapy at diagnosis with multiple agents followed by a maintenance phase of treatment might offer significant benefits to the patient.
This open-label pilot study is the first to investigate the potential efficacy and safety of a first-line combination strategy in consecutive patients with PAH in contrast to the "add-on" strategy for combination therapy. It will serve as the basis on which to consider larger, multicenter investigations of this strategy.
- Hoeper M, et al. Eur Respir J. 2005 Nov;26(5):858-63.
- Halpern SD, et al. Proc Am Thorac Soc. 2008 Jul 15;5(5):631-5.
- Provencher S, et al. Chest. 2005 Dec;128(6 Suppl):622S-628S.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247116
|Contact: Naushad Hirani, MDfirstname.lastname@example.org|
|Contact: Jean Marks, RNemail@example.com|
|University of Calgary, Peter Lougheed Hospital||Recruiting|
|Calgary, Alberta, Canada, T1Y 6J4|
|Principal Investigator:||Naushad Hirani, MD||University of Calgary|