Study of Pulmonary Hypertension in Patients With Chronic Myeloproliferative Disorders at Sohag University Hospital

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04843475
Collaborator
(none)
150
20

Study Details

Study Description

Brief Summary

Pulmonary hypertension (PH) is a complex condition that may be related to many clinical conditions. It is a serious disorder with a high morbidity and mortality rates. PH is classified into five groups according to clinical characteristics, pathological findings, hemodynamic characteristics and treatment response (Galie N, et al., 2016). These five groups include pulmonary arterial hypertension, PH due to left sided heart disease, PH due to lung disease and/or hypoxia, chronic thromboembolic pulmonary hypertension, or other pulmonary arterial obstruction and PH with unclear and/or multifactorial mechanisms (Simonneau G, et al., 2013).

PH is a major complication of several hematologic disorders including myeloproliferative neoplasms (MPNs). MPNs are a group of diseases characterized by uncontrolled proliferation of at least one myeloid series due to an abnormal hematopoietic cell clone. There are different types of MPNs including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) & chronic myeloid leukemia ( CML). Myeloproliferative neoplasms (MPNs) are included in group 5 PH (Arber DA, et al., 2016).

This study will analyze the clinical and laboratory data of MPNs patients and correlate them with development of PH in these patients aiming to identify parameters that can predict PH in MPNs patients and thus, identifying MPNs patients at highest risk for PH who require close monitoring & screening for PH hoping that early detection and management of PH in MPNs patients can improve morbidity, prognosis and survival in those patients

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Echocardiography

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Study of Pulmonary Hypertension in Patients With Chronic Myeloproliferative Disorders at Sohag University Hospital
Anticipated Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
MPNs patients who have echocardiographic probability of PH.

Diagnostic Test: Echocardiography
Trans-thoracic Echocardiography

MPNs patients who do not have echocardiographic probability of PH

Diagnostic Test: Echocardiography
Trans-thoracic Echocardiography

Outcome Measures

Primary Outcome Measures

  1. Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients [2 years]

    Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients

Secondary Outcome Measures

  1. Identification of independent different predictors of pulmonary hypertension in chronic myeloproliferative disorders patients [2 years]

    Identification of independent different predictors of pulmonary hypertension in chronic myeloproliferative disorders patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients over 18 years old.

  • Patients diagnosed with polycythemia vera, essential thrombocythemia, primary myelofibrosis and chronic myeloid leukemia according to the 2016 WHO classification and attended the outpatient Hematology Clinic at Sohag University Hospital.

Exclusion Criteria:
  • Patients less than 18 years old.

  • Patients with pre-existing pulmonary hypertension from any other cause.

  • Patients with left sided heart disease e.g. left sided heart failure, left sided valvular diseases, cardiomyopathies, left ventricular systolic or diastolic dysfunction.

  • Patients with chronic lung disease e.g. COPD & interstitial lung disease.

  • Patients with chronic kidney disease.

  • Patients with connective tissue diseases.

  • Patients with congenital heart diseases.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mahmoud Hamdy Ahmed, assistant lecturer, Sohag University
ClinicalTrials.gov Identifier:
NCT04843475
Other Study ID Numbers:
  • Soh-Med-21-04-15
First Posted:
Apr 13, 2021
Last Update Posted:
Apr 15, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2021