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NCT Number: NCT06615414

Cardiovascular Manifestations in Ph-negative MPN

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

participants are not assigned an intervention as part of the study

Other

participants are not assigned an intervention as part of the study

Other names: participants are not assigned an intervention as part of the study.

Primary outcomes

  1. 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

  1. Subclinical Cardiovascular Manifestations and Comparison with the healthy control group

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

    Subclinical cardiovascular manifestations will be detected by using of imaging techniques such as:

    • Carotid artery doppler ultrasound
    • limb doppler ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Viola Waheed Saeed

CONTACT

[email protected]

+20 109 605 0888

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Clinical and Subclinical Cardiovascular Manifestations in Philadelphia Negative Myeloproliferative Neoplasms

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 26, 2024
Registry last updated
Sep 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.