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

This study is not yet open for participant recruitment.
Verified June 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Shoshan Perek, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01884974
First received: June 20, 2013
Last updated: June 21, 2013
Last verified: June 2013
  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 Carmel Medical Center:

Primary Outcome Measures:
  • pulmonary hypertension [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 20, 2013
Last Updated: June 21, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on April 23, 2014