Cardiovascular Manifestations in Ph-negative MPN

September 24, 2024 updated by: Viola Waheed Saad, Assiut University

Clinical and Subclinical Cardiovascular Manifestations in Philadelphia Negative Myeloproliferative Neoplasms

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

80

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

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

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of adults aged 18-75 years Participants with MPN will be recruited from clinical Haematology Unit of the Internal Medicine at Assiut university while healthy participants will be recruited from health care workers Inclusion criteria of MPN patients will include individuals diagnosed with myeloproliferative neoplasms: essential thrombocythemia, Polycythemia vera and Primary myelofibrosis Exclusion criteria of MPN patients will encompass individuals with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) , 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 and Active malignancies other than MPN and pregnant and lactating women Study will take place in Assiut university hospitals

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.

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
40 MPN patients

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.
Other: participants are not assigned an intervention as part of the study
participants are not assigned an intervention as part of the study
Other Names:
  • participants are not assigned an intervention as part of the study.
40 healthy patients
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
Other: participants are not assigned an intervention as part of the study
participants are not assigned an intervention as part of the study
Other Names:
  • participants are not assigned an intervention as part of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 4 years

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)

October 1, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

September 15, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 26, 2024

Study Record Updates

Last Update Posted (Actual)

September 26, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVD in MPN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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