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First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Actelion
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT01247116
First received: November 23, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 23, 2010
November 23, 2010
December 2009
December 2012   (final data collection date for primary outcome measure)
6 minute walk test distance [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension
First-line Bosentan and Sildenafil Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study

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.

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.

  1. Hoeper M, et al. Eur Respir J. 2005 Nov;26(5):858-63.
  2. Halpern SD, et al. Proc Am Thorac Soc. 2008 Jul 15;5(5):631-5.
  3. Provencher S, et al. Chest. 2005 Dec;128(6 Suppl):622S-628S.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Hypertension, Pulmonary
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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%
Both
18 Years to 85 Years
No
Contact: Naushad Hirani, MD 403-943-4723 nhirani@ucalgary.ca
Contact: Jean Marks, RN 403-943-4723 jean.marks@albertahealthservices.ca
Canada
 
NCT01247116
BSC-UOC-2009
No
Naushad Hirani, Clinical Assistant Professor, University of Calgary
University of Calgary
Actelion
Principal Investigator: Naushad Hirani, MD University of Calgary
University of Calgary
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP