Early Therapy of Pulmonary Arterial Hypertension
Information source: Medical University of Graz
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Hypertension; Systemic Sclerosis
Intervention: Bosentan (Drug)
Phase: N/A
Status: Completed
Sponsored by: Medical University of Graz Official(s) and/or principal investigator(s): Horst Olschewski, MD, Principal Investigator, Affiliation: Medical University of Graz
Summary
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.
Clinical Details
Official title: Early Therapy of Pulmonary Arterial Hypertension
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: pulmonary vascular resistance, peak oxygen uptake
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
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Medical University of Graz, Pulmonology, Graz 8036, Austria
Additional Information
Starting date: January 2008
Last updated: September 22, 2011
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