Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases
1 other identifier
observational
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedSeptember 9, 2015
September 1, 2015
2.9 years
October 10, 2012
September 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pulmonary arterial pressure
at baseline
Secondary Outcomes (1)
change of pulmonary arterial pressure
between baseline and after 6 months
Study Arms (1)
myeloproliferative disorders
Echocardiography, spiroergometry, cardiac catheterization
Interventions
patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated
Eligibility Criteria
patients with myeloproliferative disorders
You may qualify if:
- Patients with myeloproliferative disorders
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz, Pulmonology
Graz, 8036, Austria
Biospecimen
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.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Horst Olschewski, MD
Medical University of Graz
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2012
First Posted
February 8, 2013
Study Start
July 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
September 9, 2015
Record last verified: 2015-09