Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases
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|ClinicalTrials.gov Identifier: NCT01787162|
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : September 9, 2015
Goal of the study is to assess the frequency of pulmonary hypertension in patients with chronic myeloproliferative diseases. In each patient an echocardiography at rest will be performed. In patients without musculoskeletal disease an exercise test (spiroergometry) will be performed. Patients with elevated SPAP at rest or with reduced exercise capacity (peak VO2 < 65%) a right heart catheterization (RHC) will be recommended. Also patients with advanced NYHA functional class (III or IV) or with typical PH findings in electrocardiogram will be advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6 MWD will be performed.
This work- up of patients allows clinical and hemodynamic evaluation.
|Condition or disease||Intervention/treatment|
|Myeloproliferative Disorders Pulmonary Hypertension||Other: Echocardiography, spiroergometry, cardiac catheterization|
Previous small studies and clinical cases have suggested a possible association between pulmonary hypertension (PH) and chronic myeloproliferative disorders (CMPD). MPD may cause PH through different mechanisms as: high cardiac output, asplenia, direct obstruction of pulmonary arteries by megakaryocytes, chronic thromboembolic endothelial pulmonary hypertension (CTEPH), porto-pulmonary hypertension (POPH). However, the exact prevalence of PH in this group of disorders is not known.
This study is designed to identify the pulmonary vascular changes and describe the prevalence of pulmonary hypertension (defined in this study as mean pulmonary arterial hypertension (mPAP) ≥25mmHg as assessed by right-heart catheterization (RHC) or systolic pulmonary arterial pressure (sPAP) ≥37mmHg (2.9 m/s) assessed by echocardiography.
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Echocardiography, spiroergometry, cardiac catheterization
Other: Echocardiography, spiroergometry, cardiac catheterization
patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated
- pulmonary arterial pressure [ Time Frame: at baseline ]
- change of pulmonary arterial pressure [ Time Frame: between baseline and after 6 months ]
Biospecimen Retention: Samples With DNA
Samples with DNA will be retained for later examinations at the Biobank, in case that the patient agrees (extra patient information).
The blood samples are taken only during routine tests.
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): NCT01787162
|Medical University of Graz, Pulmonology|
|Graz, Austria, 8036|
|Principal Investigator:||Horst Olschewski, MD||Medical University of Graz|