Clinical trial · Observational

Cardiovascular Manifestations in Ph-negative MPN

Clinical and Subclinical Cardiovascular Manifestations in Philadelphia Negative Myeloproliferative Neoplasms

NCT06615414CI-TRIAL-00081071not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Philadelphia Negative Myeloproliferative Neoplasms	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
participants are not assigned an intervention as part of the study	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
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.
interventionNames
1. Other: participants are not assigned an intervention as part of the study
label
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
interventionNames

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (7)

BACKGROUNDGuglielmelli 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
BACKGROUNDLeiva 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
BACKGROUNDHultcrantz 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
BACKGROUNDTefferi 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
BACKGROUNDFidler 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
BACKGROUNDGarypidou 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.