Cardiovascular Manifestations in Ph-negative MPN

Assiut University

Status: Not yet enrolling

Conditions: Philadelphia Negative Myeloproliferative Neoplasms

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

Study type: Observational

Funder types: Other

Identifiers

NCT06615414

CVD in MPN

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

40 MPN patients

Description:

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:

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

40 healthy patients

Description:

An external control group will consist of age- and gender-matched individuals without any hematological disorders or significant cardiovascular conditions. They will be recruited from health care workers

Treatment:

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