Cardiac Changes in Myeloproliferative Neoplasms

Myeloproliferative Neoplasm Clinical Trial

Official title:

Functional and Morphological Cardiac Changes in Myeloproliferative Neoplasms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03177928
• Other study ID #: CCMPNS
• Status: Not yet recruiting
• Phase: N/A
• First received: May 25, 2017
• Last updated: June 5, 2017
• Start date: September 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: Osama A Ibrahim, Proffessor.
• Phone: 00201006372498
• Email: oibrahiem[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Myeloproliferative neoplasms are heterogeneous group of clonal hematopoietic stem cell neoplasms with excessive proliferation of one or more of the erythroid, megakaryocytic, or myeloid lineages and relatively normal maturation resulting in increased numbers of red cells, platelets, and/or granulocytes in the peripheral blood. Constitutive tyrosine kinase activation appears to be a common pathogenetic mechanism.

Description:

According to worldwide study of prevalence of myeloproliferative neoplasms revealed:

Incidence of polycythemia vera ranged 0.01 to 2.61 per 100.000 population and the prevalence ranging from 0.49 to 46.88 per 100.000 population. Incidence of essential thrombocythemia is 0.21 to 2.27 per 100.000 population, prevalence ranging between 11.00 - 42.51 per 100.000 population.

Primary myelofibrosis incidence is 1.15 -4.99 per 100.000 population and prevalence ranging between 1.76 - 4.05 per 100.000 population.In previous studies, cardiac involvement including coronary arterial thrombosis, myocardial infarction, pulmonary hypertension, asymptomatic pericardial effusion, cardiac tamponade, intractable cardiac failure due to intraventricular stenosis and valvular stenosis that occur in myeloproliferative neoplasms. There is a few number of studies in which cardiac lesions were evaluated in myeloproliferative neoplasms by using transthoracic echocardiography but still inadequate, so we need to understand more about cardiovascular complications in myeloproliferative neoplasms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 28, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnostic criteria of myeloproliferative neoplasms.

Exclusion Criteria:

• Extreme body weight e.g., morbid obesity.

• Cardiac disease.

• Cerebrovascular disorders.

• Diabetes mellitus.

• Dyslipidemia.

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms

Intervention

Device:
• Transthorathic echocardiogram
In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

Barbui T, Thiele J, Gisslinger H, Finazzi G, Vannucchi AM, Tefferi A. The 2016 revision of WHO classification of myeloproliferative neoplasms: Clinical and molecular advances. Blood Rev. 2016 Nov;30(6):453-459. doi: 10.1016/j.blre.2016.06.001. Epub 2016 Jun 11. Review. — View Citation

Campbell A. Now I know why. Front Nurs Serv Q Bull. 1968 Winter;43(3):7-9. — View Citation

How common are myeloproliferative neoplasms? A systematic review and meta-analysis. Am J Hematol. 2015 Sep;90(9):850. doi: 10.1002/ajh.23984. Epub 2015 Mar 30. — View Citation

Mehta J, Wang H, Iqbal SU, Mesa R. Epidemiology of myeloproliferative neoplasms in the United States. Leuk Lymphoma. 2014 Mar;55(3):595-600. doi: 10.3109/10428194.2013.813500. Epub 2013 Jul 29. — View Citation

Passamonti F, Maffioli M. Update from the latest WHO classification of MPNs: a user's manual. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):534-542. Review. — View Citation

Titmarsh GJ, Duncombe AS, McMullin MF, O'Rorke M, Mesa R, De Vocht F, Horan S, Fritschi L, Clarke M, Anderson LA. How common are myeloproliferative neoplasms? A systematic review and meta-analysis. Am J Hematol. 2014 Jun;89(6):581-7. Review. Erratum in: Am J Hematol. 2015 Sep;90(9):850. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with cardiac complications in myeloproliferative diseases.	cardiac complications as valvular changes, ejection fraction changes, pulmonary hypertension	30 minutes