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

June 15, 2015 updated by: Shoshan Perek, Carmel Medical Center

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:

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 34632
        • Recruiting
        • Pulmonology Institute, Carmel Medical Center
        • Contact:
          • Shoshan Perek, MD
          • Phone Number: 972-4-8250517
        • Principal Investigator:
          • Shoshan Perek, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients diagnosed with Myeloproliferative disease and followed up at the Carmel Hematology Unit

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Time Frame
St George Respiratory Questionnaire
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Shoshan Perek, MD, Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (ESTIMATE)

June 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-12-0060-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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