Clinical Trial: The Early Recognition of Pulmonary Arterial Hypertension
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Early Recognition of Pulmonary Arterial Hypertension
Brief Summary: The early detection of pulmonary arterial hypertension may help to improve prognosis of the disease. It is assumed that in the early stages of pulmonary arterial hypertension, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased pulmonary arterial pressure during exercise. In the present study we investigate patients with risk factors for pulmonary arterial hypertension (e.g. connective tissue disease) by combining exercise tricuspid echo doppler and cardiopulmonary exercise test to screen patients for exercise-induced pulmonary hypertension and control the results by the gold standard right heart catheterisation at rest and during exercise. We expect that using this screening method, patients with pulmonary arterial hypertension would be recognized earlier.
Detailed Summary:
Pulmonary arterial hypertension (PAH) is a rare, life-threatening disease. It is characterised by the elevation of pulmonary arterial pressure and pulmonary vascular resistance. A remodelling of small pulmonary vessels characterised by the proliferation of the adventitia, the hypertrophy of the media and fibrosis of the intima can be observed on the microscopic level.
According to the actual classification of Venice (2003), PAH can be idiopathic, familiar or associated to other diseases and conditions (APAH). About 15 different clinical entities belong to the APAH group: connective tissue diseases such as systemic sclerosis, mixed connective tissue disease, or systemic lupus erythematodes being among the most frequent. The development of APAH in these diseases results in decreased survival. Successful therapies include prostanoids, endothelin receptor antagonists and phosphodiesterase-5 inhibitors, however, the effects in associated conditions appear smaller compared to idiopathic PAH. The early recognition of APAH may promote better treatment results and prognosis.
Hemodynamically, PAH has been defined as a mean pulmonary arterial pressure (MPAP) > 25mmHg at rest, or > 30mmHg during exercise.
It is assumed that in the early stages of PAH, pulmonary arterial pressure values may be normal at rest, but the remodelling of small arteries leads to stiffening resulting in increased pulmonary arterial pressure during exercise (latent PAH).
Doppler echocardiography, by using the tricuspid regurgitation jet and the simplified Bernoulli-equation, is a well established clinical method for the estimation of systolic pulmonary arterial pressure at rest (rSPAP). A close correlation between rSPAP values from echo and right heart cath
Sponsor: Medical University of Graz
Current Primary Outcome: pulmonary arterial pressure [ Time Frame: measurements with right heart catheterisation within 1 month after exercise tricuspid doppler ]
Original Primary Outcome: Same as current
Current Secondary Outcome: exercise capacity (peakVO2, 6 minute walk distance) [ Time Frame: controlled at 1 year after baseline ]
Original Secondary Outcome: Same as current
Information By: Medical University of Graz
Dates:
Date Received: January 24, 2008
Date Started: April 2006
Date Completion:
Last Updated: January 11, 2012
Last Verified: January 2012
