Myeloproliferative DisordersMPNPHNCT02580903
Pulmonary Hypertension in Patients With Myeloproliferative Neoplasms
An observational study of Myeloproliferative Disorders and Pulmonary Hypertension, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This is an observational prospective study aiming to clarify the prevalence of pulmonary hypertension in patients with Myeloproliferative Neoplasms and their prognosis. All patients attending our department with the above mentioned neoplasms will be offered inclusion in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disorders, Pulmonary Hypertension
- What is being tested?
- Radiology
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending our outpatient clinic with Myeloproliferative Neoplasms
Who may be able to join
- Myeloproliferative Neoplasms (PV, ET, PMF according to WHO classification)
Who cannot join
- Pregnancy
- Lack of informed consent
- Age < 18 years
- Cognitive dysfunctions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Hypertension in Patients With Philadelphia Chromosome Negative Myeloproliferative Neoplasms; an Observational Prospective Study
This is an observational prospective study aiming to clarify the prevalence of pulmonary hypertension in patients with Myeloproliferative Neoplasms and their prognosis.
All patients attending our department with the above mentioned neoplasms will be offered inclusion in this study. All will have an echo performed and patients identified as being at risk of pulmonary hypertension will be offered complete investigation as specified by the European Cardiology Association.
All patients will be followed up for a total of five years to identify prognosis.
- Being tested
- Radiology
- 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.
RadiologyRadiation
Only a small subsample will require CT and right heart catherisation
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pulmonary hypertension at initial presentation and first echo
Measured: Initial recruitment
Secondary outcomes (2)
Mortality
Measured: 1 and 5 years
Incidence of pulmonary hypertension while under follow-up
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2018
- Study completionFeb 2020
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 Odense University HospitalThe 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Brabrand, Odense University Hospital
- Investigators
- Mette Brabrand, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580903
- Sponsor's protocol ID
- MPNPH
- Acronym
- MPNPH
- Status last verified
- Sep 2020
- First submitted
- 31 Jan 2015
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Hypertension in Patients With Philadelphia Chromosome Negative Myeloproliferative Neoplasms; an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT02580903
- Acronym / sponsor ID
- MPNPH / MPNPH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 20 Oct 2015 (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.
This is an observational prospective study aiming to clarify the prevalence of pulmonary hypertension in patients with Myeloproliferative Neoplasms and their prognosis.
All patients attending our department with the above mentioned neoplasms will be offered inclusion in this study. All will have an echo performed and patients identified as being at risk of pulmonary hypertension will be offered complete investigation as specified by the European Cardiology Association.
All patients will be followed up for a total of five years to identify prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending our outpatient clinic with Myeloproliferative Neoplasms
Key inclusion criteria (1 listed)
- Myeloproliferative Neoplasms (PV, ET, PMF according to WHO classification)
Key exclusion criteria (4 listed)
- Pregnancy
- Lack of informed consent
- Age < 18 years
- Cognitive dysfunctions
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 |
|---|---|---|
| RadiologyOnly a small subsample will require CT and right heart catherisation | Radiation | – |
Primary outcome
Prevalence of pulmonary hypertension at initial presentation and first echo
Time frame: Initial recruitment
2 secondary outcomes
Mortality
Time frame: 1 and 5 years
Incidence of pulmonary hypertension while under follow-up
Time frame: 5 years
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 16 Sep 2020.
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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.
Mette Brabrand, MD principal investigator
Odense University Hospital
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 Odense University Hospital at 1 site in Denmark.
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 4 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 16 Sep 2020. 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 Denmark. 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?
Prevalence of pulmonary hypertension at initial presentation and first echo (time frame: Initial recruitment). 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 16 Sep 2020.