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

Pulmonary Hypertension Clinical Trial

— PH-MPD1  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01884974
• Other study ID #: CMC-12-0060-CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 20, 2013
• Last updated: June 15, 2015
• Start date: July 2013

Study information

• Verified date: June 2015
• Source: Carmel Medical Center
• Contact: Shoshan Perek, MD
• Phone: 972-4-8250517
• Email: shoshanpe[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Myeloproliferative Disease
• Myeloproliferative Disorders
• Pulmonary Hypertension

Intervention

Other:
• myeloproliferative disease
Echocardiogram, demographic data, St George respiratory questioner

Locations

Country	Name	City	State
Israel	Pulmonology Institute, Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	St George Respiratory Questionnaire		1 year	No