Myeloproliferative DiseasePH-MPD1NCT01884974
A Case Control Study of the Prevalence of Pulmonary Hypertension in Patients With Myeloproliferative Diseases.
An observational study of Myeloproliferative Disease and Pulmonary Hypertension, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative diseases (CMPD) associated with pulmonary hypertension were included in the group 5 category, corresponding to PH for which the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disease, Pulmonary Hypertension
- What is being tested?
- myeloproliferative disease
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Jun 2016
- 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 diagnosed with Myeloproliferative disease and followed up at the Carmel Hematology Unit
Who may be able to join
- 1) consenting patients diagnosed with a myeloproliferative disease
Who cannot join
- 1) Refusal to have an echocardiogram or answer the St. George respiratory questionnaire
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pulmonology Institute, Carmel Medical Center
Haifa, 34632
Shoshan Perek, MD, 972-4-8250517
Shoshan Perek, MD
About this study
Official title: A Case Control Study of the Prevalence of Pulmonary Hypertension in Patients With Myeloproliferative Diseases, and Correlation Between Patients Epidemiologic and Clinical Status and the Development of Pulmonary Hypertension.
Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative diseases (CMPD) associated with pulmonary hypertension were included in the group 5 category, corresponding to PH for which the aetiology is unclear and/or multifactorial. CMPD include chronic myelogenous leukaemia, chronic neutrophilic leukaemia and chronic eosinophilic leukaemia (which primarily express a myeloid phenotype and polycythaemia vera), idiopathic myelofibrosis, and essential thrombocytosis in which erythroid or megakaryocytic hyperplasia predominates.
The purpose of this research:
- Assess Prevalence of PH in patients with CMPD in Northern Israel
- Describe the demographics and clinical course in patients with CMPD who are diagnosed with PH.
Read the detailed description
study will include the following:
- sex
- age
- BMI
- ethnicity
- age diagnosed with Myeloproliferative disease
- clinical manifestations of the myeloproliferative disease
- JAK2 mutation
- known hematological complications
- Conditions
- Myeloproliferative Disease, Pulmonary Hypertension
- Being tested
- myeloproliferative disease
- Keywords
- Myeloproliferative disease, Pulmonary Hypertension
- 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.
myeloproliferative diseaseOther
Echocardiogram, demographic data, St George respiratory questioner
| Study group | Role | What they receive |
|---|---|---|
| myeloproliferative disease | Patients with Myeloproliferative Diseases as specified under inclusion and exclusion criteria Receives: Other: myeloproliferative disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary hypertension
all patients with myeloproliferative diseases in the study will be evaluated by an echocardiogram. Pulmonary hypertension will be considered when the average pulmonary arterial pressure is equal or above 25 mmHg.
Measured: 1 year
Secondary outcomes (1)
St George Respiratory Questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoshan Perek, Carmel Medical Center
- Investigators
- Shoshan Perek, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884974
- Sponsor's protocol ID
- CMC-12-0060-CTIL
- Acronym
- PH-MPD1
- Status last verified
- Jun 2015
- First submitted
- 20 Jun 2013
- Last updated
- 16 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Control Study of the Prevalence of Pulmonary Hypertension in Patients With Myeloproliferative Diseases, and Correlation Between Patients Epidemiologic and Clinical Status and the Development of Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT01884974
- Acronym / sponsor ID
- PH-MPD1 / CMC-12-0060-CTIL
- Conditions
- Myeloproliferative Disease, Pulmonary Hypertension
- Keywords
- Myeloproliferative disease, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (estimated)
- First posted
- 24 Jun 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.
Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative diseases (CMPD) associated with pulmonary hypertension were included in the group 5 category, corresponding to PH for which the aetiology is unclear and/or multifactorial. CMPD include chronic myelogenous leukaemia, chronic neutrophilic leukaemia and chronic eosinophilic leukaemia (which primarily express a myeloid phenotype and polycythaemia vera), idiopathic myelofibrosis, and essential thrombocytosis in which erythroid or megakaryocytic hyperplasia predominates.
The purpose of this research:
- Assess Prevalence of PH in patients with CMPD in Northern Israel
- Describe the demographics and clinical course in patients with CMPD who are diagnosed with PH.
Detailed description
study will include the following:
- sex
- age
- BMI
- ethnicity
- age diagnosed with Myeloproliferative disease
- clinical manifestations of the myeloproliferative disease
- JAK2 mutation
- known hematological complications
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myeloproliferative disease | – | Other: myeloproliferative diseasePatients with Myeloproliferative Diseases as specified under inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with Myeloproliferative disease and followed up at the Carmel Hematology Unit
Key inclusion criteria (1 listed)
- 1) consenting patients diagnosed with a myeloproliferative disease
Key exclusion criteria (1 listed)
- 1) Refusal to have an echocardiogram or answer the St. George respiratory questionnaire
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 |
|---|---|---|
| myeloproliferative diseaseEchocardiogram, demographic data, St George respiratory questioner | Other | myeloproliferative disease |
Primary outcome
pulmonary hypertension
Time frame: 1 year
all patients with myeloproliferative diseases in the study will be evaluated by an echocardiogram. Pulmonary hypertension will be considered when the average pulmonary arterial pressure is equal or above 25 mmHg.
1 secondary outcome
St George Respiratory Questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 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.
Shoshan Perek, MD principal investigator
Carmel Medical Center
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 Disease and Pulmonary Hypertension, run by Carmel Medical Center at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Jun 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shoshan Perek, MD (972-4-8250517, shoshanpe@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary hypertension (time frame: 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 16 Jun 2015.