A Case Control Study of the Prevalence of Pulmonary Hypertension in Patients With Myeloproliferative Diseases.

NCT01884974 | Unknown DMC

• 1 other identifier: CMC-12-0060-CTIL
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Myeloproliferative Disease; Pulmonary Hypertension

Keywords

Myeloproliferative disease; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• St George Respiratory Questionnaire

  1 year

Study Arms (1)

myeloproliferative disease

Patients with Myeloproliferative Diseases as specified under inclusion and exclusion criteria

Other: myeloproliferative disease

Interventions

myeloproliferative disease OTHER

Echocardiogram, demographic data, St George respiratory questioner

myeloproliferative disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \) consenting patients diagnosed with a myeloproliferative disease

You may not qualify if:

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

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Pulmonology Institute, Carmel Medical Center

Haifa, 34632, Israel

RECRUITING

MeSH Terms

Conditions

Myeloproliferative Disorders; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shoshan Perek, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shoshan Perek, MD

CONTACT

972-4-8250517; shoshanpe@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Shoshan Perek

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 24, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2016
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

IL (1)