Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Myeloproliferative Disorders
Pulmonary Hypertension
Other: Echocardiography, spiroergometry, cardiac catheterization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • pulmonary arterial pressure [ Time Frame: at baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of pulmonary arterial pressure [ Time Frame: between baseline and after 6 months ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 43
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
myeloproliferative disorders
Echocardiography, spiroergometry, cardiac catheterization
Other: Echocardiography, spiroergometry, cardiac catheterization
patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with myeloproliferative disorders

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01787162

Locations
Austria
Medical University of Graz, Pulmonology Recruiting
Graz, Austria, 8036
Contact: Horst Olschewski, MD    +46-316-385-12183    horst.olschewski@medunigraz.at   
Contact: Xhylsime Kqiku, MD    +43-316-385-80048    xhylsime.kqiku@medunigraz.at   
Principal Investigator: Horst Olschewski, MD         
Sub-Investigator: Xhylsime Kqiku, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Horst Olschewski, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01787162     History of Changes
Other Study ID Numbers: 24-393 ex 11/12
Study First Received: October 10, 2012
Last Updated: February 18, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Graz:
Myeloproliferative disorders
pulmonary hypertension
pulmonary vascular diseases

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Myeloproliferative Disorders
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014