Early Therapy of Pulmonary Arterial Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Early Therapy of Pulmonary Arterial Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909337
• Other study ID #: 18-295 ex 06/07
• Status: Completed
• Phase: N/A
• First received: May 27, 2009
• Last updated: September 22, 2011
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2011
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

Drug:
• Bosentan
2x62.5mg for 4 weeks, then 2x125mg

Locations

Country	Name	City	State
Austria	Medical University of Graz, Pulmonology	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	Actelion

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy	No
Secondary	pulmonary vascular resistance, peak oxygen uptake		12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy	No