The Early Recognition of Pulmonary Arterial Hypertension
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|ClinicalTrials.gov Identifier: NCT00609349|
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : January 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Device: ETED, CPET, RHC||Not Applicable|
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 catheterisation (RHC) has been described. A promising non-invasive method to detect SPAP during exercise is Exercise Tricuspid Echo Doppler (ETED). Previous studies suggested, that SPAP during exercise can be assessed with ETED in patients with connective tissue diseases, and it was suggested that a considerable proportion of these patients suffered from latent PAH. However, the results of these studies were not controlled by the gold standard RHC. According to present guidelines, RHC is needed for the definite diagnosis of PAH, which allows the precise measurement of MPAP, pulmonary arterial wedge pressure, right atrial pressure and cardiac output, and the calculation of pulmonary vascular resistance.
Cardiopulmonary exercise testing (CPET) is a reliable method to objectively evaluate exercise capacity. Patients with latent PAH may suffer from dyspnea and early fatigue during exercise and may have a reduced exercise capacity. A low peak O2 uptake was associated with a poor prognosis in patients with PAH.
In the present study we investigate patients with risk factors for PAH by combining ETED and CPET and control the results by RHC at rest and during exercise.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Early Recognition of Pulmonary Arterial Hypertension|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
connective tissue disease
all patients suffer from a connective tissue disease representing a risk for the development of pulmonary hypertension
Device: ETED, CPET, RHC
exercise tricuspid echo doppler (ETED): allows the estimation of systolic pulmonary arterial pressure at exercise cardiopulmonary exercise test (CPET) allows to measures exercise capacity (peakVO2)
right heart catheterisation (RHC): is the gold standard for the measurement of pulmonary arterial pressure values
- pulmonary arterial pressure [ Time Frame: measurements with right heart catheterisation within 1 month after exercise tricuspid doppler ]
- exercise capacity (peakVO2, 6 minute walk distance) [ Time Frame: controlled at 1 year after baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609349
|Medical University Graz, Division of Pulmonology|
|Graz, Steiermark, Austria, 8036|
|Principal Investigator:||Horst Olschewski, MD||Medical University of Graz|