Early Therapy of Pulmonary Arterial Hypertension

This study has been completed.
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00909337
First received: May 27, 2009
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

Exercise-induced increase of the pulmonary arterial pressure may be an early sign of pulmonary arterial hypertension. It has been shown that patients with normal pulmonary arterial pressure at rest but elevated pulmonary arterial pressure during exercise have a decreased exercise-capacity and may have a worse prognosis compared to patients with normal pulmonary arterial pressure values at rest and during exercise. According to the currently used definition pulmonary hypertension can be diagnosed if the mean pulmonary arterial pressure is higher than 25mmHg at rest or 30mmHg during exercise. In this study patients with a risk for pulmonary arterial hypertension (connective tissue disease) and increased pulmonary arterial pressure values during exercise are receiving a therapy with a dual endothelin receptor antagonist - bosentan, a therapy established for pulmonary arterial hypertension. The therapy effect is than compared to the recorded changes before the introduction of this therapy.


Condition Intervention
Pulmonary Hypertension
Systemic Sclerosis
Drug: Bosentan

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Therapy of Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Change of mean pulmonary arterial pressure at 50W under therapy with Bosentan compared to change of mean pulmonary arterial pressure at 50W before the introduction of therapy with Bosentan [ Time Frame: 12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pulmonary vascular resistance, peak oxygen uptake [ Time Frame: 12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Bosentan
In this study, all participants have normal pulmonary arterial pressure at rest and elevated pulmonary arterial pressure during exercise. First, they were followed up for a year and were controlled after 1 year without specific therapy for pulmonary hypertension. Then Bosentan was introduced. A second control showing the effects of the therapy was done after 6 months. The changes in the "therapy period" can be compared with the changes in the "follow up period".
Drug: Bosentan
2x62.5mg for 4 weeks, then 2x125mg
Other Name: Tracleer

Detailed Description:

Bosentan is an established therapy in pulmonary arterial hypertension, which may be diagnosed when the mean pulmonary arterial pressure is >25mmHg at rest or >30mmHg at exercise. Bosentan has shown efficacy, if mean pulmonary arterial pressure was elevated at rest. However, there are no data available of the effects of such a therapy, if the mean pulmonary arterial pressure is normal at rest but elevated during exercise. The purpose of this study is to provide additional data on this group of patients. Our hypothesis is that patients with exercise-induced pulmonary hypertension may show a gradual worsening of pulmonary hemodynamics and potentially a development of manifest pulmonary arterial hypertension (elevated resting pulmonary arterial pressure values) without treatment, while the introduction of Bosentan may improve hemodynamics and exercise capacity in this patient group.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • exercise-induced pulmonary hypertension
  • systemic sclerosis

Exclusion Criteria:

  • relevant pulmonary obstruction or restriction
  • relevant left cardiac disease
  • recent changes in medical therapy
  • recent major operations
  • recent major cardiovascular diseases
  • inability to perform exercise
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909337

Locations
Austria
Medical University of Graz, Pulmonology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Actelion
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

No publications provided by Medical University of Graz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT00909337     History of Changes
Other Study ID Numbers: 18-295 ex 06/07
Study First Received: May 27, 2009
Last Updated: September 22, 2011
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014