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Cardiovascular Manifestations in Ph-negative MPN

Clinical and Subclinical Cardiovascular Manifestations in Philadelphia Negative Myeloproliferative Neoplasms

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06615414
Enrollment
80
Registered
2024-09-26
Start date
2024-10-31
Completion date
2029-10-31
Last updated
2024-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Philadelphia Negative Myeloproliferative Neoplasms

Keywords

Cardiovascular manifestations

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.

Interventions

participants are not assigned an intervention as part of the study

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Cardiovascular Disease and cardiovascular Risk Factorsthrough study completion, an average of 4 yearsAssessment 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

MeasureTime frameDescription
Subclinical Cardiovascular Manifestations and Comparison with the healthy control groupthrough study completion, an average of 4 yearsSubclinical cardiovascular manifestations will be detected by using of imaging techniques such as: * Carotid artery doppler ultrasound * limb doppler ultrasound

Contacts

Primary ContactViola Waheed Saeed
violawaheed2@gmail.com+20 109 605 0888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026