Prevalence and Risk Factors of Pulmonary Hypertension in Patients with Myeloproliferative Neoplasms in Assiut University Hospital.

October 17, 2024 updated by: Abdelrhman Khalaf Hadyia Mohamed, Assiut University
This study will evaluate the MPNs patients for the presence of PH by using a non invasive method ( Transthoracic echocardiography (TTE )) and correlate the clinical and laboratory data of these patients with development of PH aiming to identify risk factors for PH and parameters that can predict PH in MPNs patients and thus,identifying MPNs patients 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pulmonary hypertension (PH) is a syndrome characterized by marked remodeling of the pulmonary vasculature and a progressive increase in the pulmonary vascular load. PH is a serious complex disorder that associated with high morbidity and mortality rates.

PH is a complication of various hematologic diseases including myeloproliferative neoplasms (MPNs) which are included in group 5 ph.

Myeloproliferative neoplasms (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), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF).

PH is defined as an elevation in the mean pulmonary artery pressure (mPAP) that is greater than or equal to 25 mmHg, which was measured at rest via right heart catheterization (RHC).

Systolic pulmonary artery pressure (sPAP) can be accurately estimated using Doppler transthoracic echocardiography (TTE), recent advances in noninvasive imaging led Doppler TTE to become the most widespread and well-recognized technique for non-invasive sPAP evaluation and the screening modality of choice for evaluating PH.

Active monitoring of PH in patients with MPN may be warranted. Identification of risk factors predicting PH in MPN patients promises early detection and possibly improved PH management and therapy.

Study Type

Observational

Enrollment (Estimated)

100

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 Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Assiut University Hospitals. (internal medicine Department and Outpatient Hematology Clinic )

Description

Inclusion Criteria:

  1. Adult patients (≥18 years)
  2. patients diagnosed with MPNs. including polycythemia vera (PV), essential thrombocythemia (ET), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF)

Exclusion Criteria:

  1. patients less than 18 years old.
  2. patients with cardiac diseases involving the left side of the heart or congenital heart diseases.
  3. patients with chronic lung disease and primary pulmonary hypertension.
  4. patients with chronic kidney disease.
  5. patients with inherited and acquired chronic hemolytic anemia.
  6. patients with connective tissue diseases.
  7. patients with with past or current pulmonary embolism.

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
MPNs patients who have echocardiographic probability of PH
Device: Transthoracic echocardiography
MPNs patients who have echocardiographic probability of PH
MPNs patients who do not have echocardiographic probability of PH
Device: Transthoracic echocardiography
MPNs patients who have echocardiographic probability of PH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine the prevalence of pulmonary hypertension in patients with MPNs at Assiut University Hospital
Time Frame: 1 year
To determine the prevalence of pulmonary hypertension in patients with MPNs at Assiut University Hospital by using a non invasive method ( Transthoracic echocardiography (TTE ))
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictors of pulmonary hypertension in MPNs patients
Time Frame: 1 year
To find the predictors of pulmonary hypertension through analysis of the data of those patients
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prevalence of PH in MPNs

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Myeloproliferative Neoplasm

Clinical Trials on Transthoracic echocardiography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe