Myeloproliferative DisorderNCT00909467
Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases
An observational study of Myeloproliferative Disorder and Myelodysplastic Syndromes, run by Medical University of Graz at 1 site in Austria.
Trial summary
Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these conditions is not known. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Myeloproliferative Disorder, Myelodysplastic Syndromes, Pulmonary Hypertension
- What is being tested?
- echocardiography, right heart catheterisation
- How many people
- 86 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2009to Nov 2011
- 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 known myeloproliferative or myelodysplastic disease as a risk factor for pulmonary hypertension
Who may be able to join
- myelodysplastic disease or myeloproliferative diseases
Who cannot join
- known pulmonary hypertension
- relevant pulmonary disease
- relevant left cardiac or valvular disease
- recent major operations
- recent changes in medications
- relevant anaemia
- inability to exercise
Trial locations and contacts
1 site in 1 country.
About this study
Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these conditions is not known. The effects of pulmonary hypertension on the clinical picture and the symptoms of patients in these conditions needs also further exploration. This exploratory study is designed to describe the prevalence of pulmonary hypertension in the population with such hematologic diseases, and the stages of pulmonary hypertension as well its effect on exercise capacity at time of diagnosis.
Read the detailed description
For early recognition of pulmonary hypertension exercise doppler echocardiography will be used in all patients. Patients with elevated pulmonary arterial pressure at rest or during exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential sign of pulmonary hypertension) are advised to undergo right heart catheterisation. Cardiopulmonary exercise testing and six-minute walk distance measurement are performed to measure exercise capacity. The described work-up of patients allows precise and objective hemodynamic and clinical evaluation.
- Being tested
- echocardiography, right heart catheterisation
- Medical subject headings
- Myeloproliferative Disorders, Myelodysplastic Syndromes, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiography, right heart catheterisationOther
Also called EDE, RHC
at each patient an echocardiography will be performed at rest and during exercise. For the evaluation of exercise capacity, cardiopulmonary exercise testing and six-minute walk is performed. Right heart catheterisation is recommended to those with suspected pulmonary hypertension.
| Study group | Role | What they receive |
|---|---|---|
| myeloproliferative, -dysplastic disease | Not described Receives: Other: echocardiography, right heart catheterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean pulmonary arterial pressure at rest and during exercise
Measured: at baseline and after 1 year
Secondary outcomes (1)
exercise capacity
Measured: at baseline and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisorderStudies 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
- 86 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, Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909467
- Sponsor's protocol ID
- 20-097 ex 08/09
- Status last verified
- Mar 2012
- First submitted
- 27 May 2009
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases
- ClinicalTrials.gov ID
- NCT00909467
- Acronym / sponsor ID
- 20-097 ex 08/09
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 May 2009 (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.
Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these conditions is not known. The effects of pulmonary hypertension on the clinical picture and the symptoms of patients in these conditions needs also further exploration. This exploratory study is designed to describe the prevalence of pulmonary hypertension in the population with such hematologic diseases, and the stages of pulmonary hypertension as well its effect on exercise capacity at time of diagnosis.
Detailed description
For early recognition of pulmonary hypertension exercise doppler echocardiography will be used in all patients. Patients with elevated pulmonary arterial pressure at rest or during exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential sign of pulmonary hypertension) are advised to undergo right heart catheterisation. Cardiopulmonary exercise testing and six-minute walk distance measurement are performed to measure exercise capacity. The described work-up of patients allows precise and objective hemodynamic and clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myeloproliferative, -dysplastic disease | – | Other: echocardiography, right heart catheterisation |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with known myeloproliferative or myelodysplastic disease as a risk factor for pulmonary hypertension
Key inclusion criteria (1 listed)
- myelodysplastic disease or myeloproliferative diseases
Key exclusion criteria (7 listed)
- known pulmonary hypertension
- relevant pulmonary disease
- relevant left cardiac or valvular disease
- recent major operations
- recent changes in medications
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, right heart catheterisationAlso: EDE, RHCat each patient an echocardiography will be performed at rest and during exercise. For the evaluation of exercise capacity, cardiopulmonary exercise testing and six-minute walk is performed. Right heart catheterisation is recommended to those with suspected pulmonary hypertension. | Other | myeloproliferative, -dysplastic disease |
Primary outcome
mean pulmonary arterial pressure at rest and during exercise
Time frame: at baseline and after 1 year
1 secondary outcome
exercise capacity
Time frame: at baseline and after 1 year
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 Mar 2012.
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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, Pulmonology
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 Disorder and Myelodysplastic Syndromes, 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 1 inclusion and 7 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 Mar 2012. 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?
mean pulmonary arterial pressure at rest and during exercise (time frame: at baseline and after 1 year). 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 Mar 2012.