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NCT Number: NCT00909337

Early Therapy of Pulmonary Arterial Hypertension

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Connective Tissue Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Sclerosis Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz, Pulmonology

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bosentan

Drug

2x62.5mg for 4 weeks, then 2x125mg

Other names: Tracleer

Primary outcomes

  1. 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

Secondary outcomes

  1. pulmonary vascular resistance, peak oxygen uptake

    Time frame: 12months before Bosentan therapy vs. at begin of bosentan therapy vs. 6months under bosentan therapy

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Actelion

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 28, 2009
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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