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Zinc Deficiency in Dilated Cardiomyopathy

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04860921
Collaborator
(none)
50
Enrollment
20.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cardiomyopathies are group of heart diseases that influence cardiac muscles directly and are not related to hypertension, congenital, valvular and pericardial diseases. The most common type of cardiomyopathy is dilate cardiomyopathy.

    Dilated cardiomyopathy usually manifests as chronic systolic heart failure leading to arrhythmias and sudden death.

    Trace elements are known to have a key role in myocardial metabolism. The human heart requires energy from micro and macro nutrients both to regenerate proteins and cells, and to support cyclic contractions. Heart failure is associated with neuro-hormonal activation leading to elevated levels of inflammatory markers and oxidative stress.

    Zinc is an essential micronutrient that impacts the cardiovascular system. There are multiple potential pathophysiologic causes for zinc deficiency in heart failure as result of impaired micronutrient consumption, hyper inflammatory state, diminished absorption and hyperzincuria from heart failure medications. Zinc deficiency may play a role as primary and possible reversible cause of dilated cardiomyopathy.

    Plasma zinc levels have been reported in multiple observational studies of patients with heart failure particularly in studies of idiopathic dilated cardiomyopathy, serum zinc levels have been found to be low.

    A small but growing body of evidence suggesting the role for oral zinc supplementation in the management of dilated cardiomyopathy however further evaluation of the impact on outcome is needed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Oral Zinc Supplementation in Children With Dilated Cardiomyopathy : Aprospective Cohort Study in Assiut ,Egypt.
    Anticipated Study Start Date :
    Apr 20, 2021
    Anticipated Primary Completion Date :
    Nov 20, 2022
    Anticipated Study Completion Date :
    Dec 28, 2022

    Outcome Measures

    Primary Outcome Measures

    1. New york heart associaton functional classification for grading heart failure [1.5 year]

      All cases included the study will be carefully examined for sings of heart failure according to new york heart association classification for grading of heart failure

    Secondary Outcome Measures

    1. Detailed echocardiographic examination [1.5 year]

      Detailed echocardiography using Phillips Envisor C according to the guidelines of the American society of echocardiography(18)ŲŒfocusing on follow up of left ventricle end diastolic dimension Z-score ,left ventricle fractional shortening and ejection fraction.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • children (1-18) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy
    Exclusion Criteria:

    • patients with congenital heart diseases.

    • patients less than one year age.

    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:
    Safaa Abdel Hameed Ahmed, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04860921
    Other Study ID Numbers:
    • Zinc in dilated cardiomyopathy
    First Posted:
    Apr 27, 2021
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Safaa Abdel Hameed Ahmed, Principal investigator, Assiut University
    Dilated cardiomopathy
    Additional relevant MeSH terms:
    Cardiomyopathies
    Cardiomyopathy, Dilated

    Study Results

    No Results Posted as of Apr 27, 2021