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A Case Control Study of the Prevalence of Pulmonary Hypertension in Patients With Myeloproliferative Diseases. (PH-MPD1)

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ClinicalTrials.gov Identifier: NCT01884974
Recruitment Status : Unknown
Verified June 2015 by Shoshan Perek, Carmel Medical Center.
Recruitment status was:  Recruiting
First Posted : June 24, 2013
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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 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:

  1. Assess Prevalence of PH in patients with CMPD in Northern Israel
  2. Describe the demographics and clinical course in patients with CMPD who are diagnosed with PH.

Condition or disease Intervention/treatment
Myeloproliferative Disease Pulmonary Hypertension Other: myeloproliferative disease

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

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Retrospective
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.
Study Start Date : July 2013
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
myeloproliferative disease
Patients with Myeloproliferative Diseases as specified under inclusion and exclusion criteria
Other: myeloproliferative disease
Echocardiogram, demographic data, St George respiratory questioner


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. St George Respiratory Questionnaire [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with Myeloproliferative disease and followed up at the Carmel Hematology Unit
Criteria

Inclusion Criteria:

1) consenting patients diagnosed with a myeloproliferative disease

Exclusion Criteria:

1) Refusal to have an echocardiogram or answer the St. George respiratory questionnaire

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884974


Contacts
Contact: Shoshan Perek, MD 972-4-8250517 shoshanpe@clalit.org.il

Locations
Israel
Pulmonology Institute, Carmel Medical Center Recruiting
Haifa, Israel, 34632
Contact: Shoshan Perek, MD    972-4-8250517      
Principal Investigator: Shoshan Perek, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Shoshan Perek, MD Carmel Medical Center
More Information

Responsible Party: Shoshan Perek, Dr Shoshan Perek, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01884974     History of Changes
Other Study ID Numbers: CMC-12-0060-CTIL
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by Shoshan Perek, Carmel Medical Center:
Myeloproliferative disease
Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Myeloproliferative Disorders
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bone Marrow Diseases
Hematologic Diseases