Cardiovascular Manifestations in Ph-negative MPN

NCT06615414 | Not Yet Recruiting

• 1 other identifier: CVD in MPN
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Philadelphia Negative Myeloproliferative Neoplasms

Keywords

Cardiovascular manifestations

Outcome Measures

Primary Outcomes (1)

• Prevalence of Cardiovascular Disease and cardiovascular Risk Factors

  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 Outcomes (1)

• Subclinical Cardiovascular Manifestations and Comparison with the healthy control group

  through study completion, an average of 4 years

Study Arms (2)

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

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

Interventions

participants are not assigned an intervention as part of the study OTHER

participants are not assigned an intervention as part of the study

Also known as: participants are not assigned an intervention as part of the study.

40 MPN patients; 40 healthy patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• Guglielmelli P, Gangat N, Coltro G, Lasho TL, Loscocco GG, Finke CM, Morsia E, Sordi B, Szuber N, Hanson CA, Pardanani A, Vannucchi AM, Tefferi A. Mutations and thrombosis in essential thrombocythemia. Blood Cancer J. 2021 Apr 27;11(4):77. doi: 10.1038/s41408-021-00470-y. No abstract available.

  PMID: 33907189 BACKGROUND

• Leiva O, Bekendam RH, Garcia BD, Thompson C, Cantor A, Chitalia V, Ravid K. Emerging Factors Implicated in Fibrotic Organ-Associated Thrombosis: The Case of Two Organs. TH Open. 2019 Jun 7;3(2):e165-e170. doi: 10.1055/s-0039-1692204. eCollection 2019 Apr.

  PMID: 31259299 BACKGROUND

• Hultcrantz M, Wilkes SR, Kristinsson SY, Andersson TM, Derolf AR, Eloranta S, Samuelsson J, Landgren O, Dickman PW, Lambert PC, Bjorkholm M. Risk and Cause of Death in Patients Diagnosed With Myeloproliferative Neoplasms in Sweden Between 1973 and 2005: A Population-Based Study. J Clin Oncol. 2015 Jul 10;33(20):2288-95. doi: 10.1200/JCO.2014.57.6652. Epub 2015 Jun 1.

  PMID: 26033810 BACKGROUND

• Tefferi A, Guglielmelli P, Larson DR, Finke C, Wassie EA, Pieri L, Gangat N, Fjerza R, Belachew AA, Lasho TL, Ketterling RP, Hanson CA, Rambaldi A, Finazzi G, Thiele J, Barbui T, Pardanani A, Vannucchi AM. Long-term survival and blast transformation in molecularly annotated essential thrombocythemia, polycythemia vera, and myelofibrosis. Blood. 2014 Oct 16;124(16):2507-13; quiz 2615. doi: 10.1182/blood-2014-05-579136. Epub 2014 Jul 18.

  PMID: 25037629 BACKGROUND

• Fidler TP, Xue C, Yalcinkaya M, Hardaway B, Abramowicz S, Xiao T, Liu W, Thomas DG, Hajebrahimi MA, Pircher J, Silvestre-Roig C, Kotini AG, Luchsinger LL, Wei Y, Westerterp M, Snoeck HW, Papapetrou EP, Schulz C, Massberg S, Soehnlein O, Ebert B, Levine RL, Reilly MP, Libby P, Wang N, Tall AR. The AIM2 inflammasome exacerbates atherosclerosis in clonal haematopoiesis. Nature. 2021 Apr;592(7853):296-301. doi: 10.1038/s41586-021-03341-5. Epub 2021 Mar 17.

  PMID: 33731931 BACKGROUND

• Garypidou V, Vakalopoulou S, Dimitriadis D, Tziomalos K, Sfikas G, Perifanis V. Incidence of pulmonary hypertension in patients with chronic myeloproliferative disorders. Haematologica. 2004 Feb;89(2):245-6. No abstract available.

  PMID: 15003906 BACKGROUND

• Briukhovetska D, Dorr J, Endres S, Libby P, Dinarello CA, Kobold S. Interleukins in cancer: from biology to therapy. Nat Rev Cancer. 2021 Aug;21(8):481-499. doi: 10.1038/s41568-021-00363-z. Epub 2021 Jun 3.

  PMID: 34083781 BACKGROUND

Central Study Contacts

Viola Waheed Saeed

CONTACT

+20 109 605 0888; violawaheed2@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 26, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share