Myeloproliferative DisordersNCT01787162
Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases
An observational study of Myeloproliferative Disorders and Pulmonary Hypertension, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Myeloproliferative Disorders, Pulmonary Hypertension
- What is being tested?
- Echocardiography, spiroergometry, cardiac catheterization
- How many people
- 43 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with myeloproliferative disorders
Who may be able to join
- Patients with myeloproliferative disorders
- Written informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Echocardiography, spiroergometry, cardiac catheterization
- Keywords
- Myeloproliferative disorders, pulmonary hypertension, pulmonary vascular diseases
- Medical subject headings
- Myeloproliferative Disorders, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography, spiroergometry, cardiac catheterizationOther
patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated
| Study group | Role | What they receive |
|---|---|---|
| myeloproliferative disorders | Echocardiography, spiroergometry, cardiac catheterization Receives: Other: Echocardiography, spiroergometry, cardiac catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary arterial pressure
Measured: at baseline
Secondary outcomes (1)
change of pulmonary arterial pressure
Measured: between baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horst Olschewski, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787162
- Sponsor's protocol ID
- 24-393 ex 11/12
- Status last verified
- Sep 2015
- First submitted
- 10 Oct 2012
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases
- ClinicalTrials.gov ID
- NCT01787162
- Acronym / sponsor ID
- 24-393 ex 11/12
- Keywords
- Myeloproliferative disorders, pulmonary hypertension, pulmonary vascular diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myeloproliferative disorders | – | Other: Echocardiography, spiroergometry, cardiac catheterizationEchocardiography, spiroergometry, cardiac catheterization |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with myeloproliferative disorders
Key inclusion criteria (2 listed)
- Patients with myeloproliferative disorders
- Written informed consent
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography, spiroergometry, cardiac catheterizationpatients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated | Other | myeloproliferative disorders |
Primary outcome
pulmonary arterial pressure
Time frame: at baseline
1 secondary outcome
change of pulmonary arterial pressure
Time frame: between baseline and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Olschewski, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Disorders and Pulmonary Hypertension, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary arterial pressure (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2015.