Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

This study is currently recruiting participants.
Verified February 2014 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01787162
First received: October 10, 2012
Last updated: February 18, 2014
Last verified: February 2014

October 10, 2012
February 18, 2014
July 2012
July 2014   (final data collection date for primary outcome measure)
pulmonary arterial pressure [ Time Frame: at baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01787162 on ClinicalTrials.gov Archive Site
change of pulmonary arterial pressure [ Time Frame: between baseline and after 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Probability Sample

patients with myeloproliferative disorders

  • Myeloproliferative Disorders
  • Pulmonary Hypertension
Other: Echocardiography, spiroergometry, cardiac catheterization
patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated
myeloproliferative disorders
Echocardiography, spiroergometry, cardiac catheterization
Intervention: Other: Echocardiography, spiroergometry, cardiac catheterization
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
43
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
No
Not Provided
Austria
 
NCT01787162
24-393 ex 11/12
Yes
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Horst Olschewski, MD Medical University of Graz
Medical University of Graz
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP