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Clinical Trials/NCT06615414
NCT06615414
Not yet recruiting
Not Applicable

Clinical and Subclinical Cardiovascular Manifestations in Philadelphia Negative Myeloproliferative Neoplasms

Assiut University0 sites80 target enrollmentOctober 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Philadelphia Negative Myeloproliferative Neoplasms
Sponsor
Assiut University
Enrollment
80
Primary Endpoint
Prevalence of Cardiovascular Disease and cardiovascular Risk Factors
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The primary aim of this research is to investigate the clinical and subclinical cardiovascular complications and its relationship with myeloproliferative neoplasms seeking to assess incidence, prevalence and severity in comparison to healthy group and analyze potential risk factors including genetic mutations, inflammatory markers and hematological parameters

Detailed Description

Myeloproliferative neoplasms (MPNs) are a group of hematological disorders characterized by clonal proliferation of stem cells leading to excessive production of blood cells. The primary types include polycythemia vera, essential thrombocythemia, and primary myelofibrosis. They share a common characteristic in that they lack the Philadelphia chromosome. Patients with MPN face an elevated risk of various clinical cardiovascular complications including arterial and venous thromboembolism, hypertension and heart failure. This increased risk can be attributed to several factors including, chronic inflammation, hyperviscosity due to increased blood cells count and genetic mutation like JAK2 V617F which plays a pivotal role in disease pathogenesis. While clinical cardiovascular events in MPN patients are well-documented, subclinical manifestations such as subclinical atherosclerosis, pulmonary hypertension, left ventriclar hypertrophy, diastolic dysfunction and arrhythmia are often overlooked. These subclinical changes may significantly contribute to morbidity and mortality but are not routinely assessed in clinical practice. Non invasive modalities such as electrocardiography, echocardiography, carotid doppler ultrasound and limb doppler ultrasound can provide vulnerable tools for early detection of these cardiovascular manifestations. So understanding the relationship between myloproliferative neoplasms and incidence and severity of cardiovascular complications is crucial. This knowledge can enhance risk assessment, improve patient care and outcomes and facilitate targeted interventions.

Registry
clinicaltrials.gov
Start Date
October 2024
End Date
October 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Viola Waheed Saad

Assistant Lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • patients with confirmed diagnosis of myeloproliferative neoplasms of one of the following:
  • Essential thrombocythemia (ET)
  • Polycythemia vera (PV)
  • Primary myelofibrosis (PMF)
  • Adults aged 18 years and older.
  • who accept to participate in the study in Assiut university hospital.

Exclusion Criteria

  • Patients with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) will be excluded.
  • Patients who have experienced a myocardial infarction, stroke, heart failure, Hypertension, or significant cardiovascular event before diagnosis of MPN
  • Patients with severe comorbid conditions that could confound results, such as:
  • Severe renal or hepatic impairment
  • Active malignancies other than MPN
  • Pregnant or lactating women should be excluded due to potential risks associated with cardiovascular evaluations.
  • at age group below 18 years old.
  • who refused to participate in the study.

Outcomes

Primary Outcomes

Prevalence of Cardiovascular Disease and cardiovascular Risk Factors

Time Frame: through study completion, an average of 4 years

Assessment of clinical cardiovascular disease (CVD) through patient history, physical examination, and diagnostic tests (e.g., ECG, echocardiography) and Measurement of risk factors such as: * Blood pressure (systolic and diastolic) * Lipid profile (total cholesterol, LDL, HDL, triglycerides) * Body mass index (BMI) kg/m\^2

Secondary Outcomes

  • Subclinical Cardiovascular Manifestations and Comparison with the healthy control group(through study completion, an average of 4 years)

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