Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

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.

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Key information

Conditions

Myeloproliferative Disorders Bone Marrow Diseases Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hypertension Hypertension, Pulmonary Lung Diseases Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Pulmonology

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Echocardiography, spiroergometry, cardiac catheterization

Other

patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated

Primary outcomes

pulmonary arterial pressure

Time frame: at baseline

Secondary outcomes

change of pulmonary arterial pressure

Time frame: between baseline and after 6 months

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Feb 8, 2013
Registry last updated: Sep 9, 2015

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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Completed