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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Shoshan Perek, Carmel Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01884974
First Posted: June 24, 2013
Last Update Posted: June 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shoshan Perek, Carmel Medical Center
  Purpose

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 Intervention
Myeloproliferative Disease Pulmonary Hypertension Other: myeloproliferative disease

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Shoshan Perek, Carmel Medical Center:

Primary Outcome Measures:
  • 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:
  • St George Respiratory Questionnaire [ Time Frame: 1 year ]

Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
myeloproliferative disease
Patients with Myeloproliferative Diseases as specified under inclusion and exclusion criteria
Other: myeloproliferative disease
Echocardiogram, demographic data, St George respiratory questioner

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
  Eligibility

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 Submitted: June 20, 2013
First Posted: June 24, 2013
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