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Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01787162
Recruitment Status : Completed
First Posted : February 8, 2013
Last Update Posted : September 9, 2015
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
myeloproliferative disorders
Echocardiography, spiroergometry, cardiac catheterization
Other: Echocardiography, spiroergometry, cardiac catheterization
patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated

Primary Outcome Measures :
  1. pulmonary arterial pressure [ Time Frame: at baseline ]

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with myeloproliferative disorders

Inclusion Criteria:

  • Patients with myeloproliferative disorders
  • Written informed consent

Exclusion Criteria:

  • Manifest pulmonary hypertension
  • Significant pulmonary disease
  • Left-sided heart failure or diastolic compliance dysfunction
  • Hemodynamic relevant valvular disease
  • Systemic arterial hypertension (at rest systolic >150 mmHg, diastolic > 90 mmHg, during exercise > 220 mmHg)
  • Severe anemia
  • Uncontrolled supraventricular and ventricular arrhythmias
  • Myocardial infarction (within the last 12 months)
  • Pulmonary embolism (within the last 12 months)
  • Recent therapy changes (within the last 12 months)
  • Recent major surgeries (within the last 12 months)
  • For exercise tests: musculoskeletal diseases which may unable the exercise tests

Information from the National Library of Medicine

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 identifier (NCT number): NCT01787162

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Medical University of Graz, Pulmonology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
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Principal Investigator: Horst Olschewski, MD Medical University of Graz

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Responsible Party: Medical University of Graz Identifier: NCT01787162     History of Changes
Other Study ID Numbers: 24-393 ex 11/12
First Posted: February 8, 2013    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015
Keywords provided by Medical University of Graz:
Myeloproliferative disorders
pulmonary hypertension
pulmonary vascular diseases
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Myeloproliferative Disorders
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bone Marrow Diseases
Hematologic Diseases