Cardiac Changes in Myeloproliferative Neoplasms

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03177928
Collaborator
(none)
40
3
17.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transthorathic echocardiogram
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Functional and Morphological Cardiac Changes in Myeloproliferative Neoplasms
Anticipated Study Start Date :
Sep 1, 2017
Anticipated Primary Completion Date :
Aug 31, 2018
Anticipated Study Completion Date :
Feb 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: study group

patients with myeloproliferative neoplasms and reveal cardiac complications by using echocardiogram, intervention by using transthorathic echocardiography for all patients.

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

Active Comparator: control group

patients with hematological disorders including myeloproliferative neoplasms without cardiac affection by using echocardiogram. Intervention will be in the form of using transthorath echocardiography with all patients to reveal any cardiac abnormalities.

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

Active Comparator: control group 2

healthy people from the same age and sex will be investigated using echocardiogram. Intervention will be in the form of using transthorathic echocardiography.

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

Outcome Measures

Primary Outcome Measures

  1. number of patients with cardiac complications in myeloproliferative diseases. [30 minutes]

    cardiac complications as valvular changes, ejection fraction changes, pulmonary hypertension

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Diagnostic criteria of myeloproliferative neoplasms.
Exclusion Criteria:
  • Extreme body weight e.g., morbid obesity.

  • Cardiac disease.

  • Cerebrovascular disorders.

  • Diabetes mellitus.

  • Dyslipidemia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
AKAli, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03177928
Other Study ID Numbers:
  • CCMPNS
First Posted:
Jun 6, 2017
Last Update Posted:
Jun 6, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2017