Zinc Deficiency in Dilated Cardiomyopathy

• Conditions: Zinc Deficiency

• Registration Number: NCT04860921
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-11-17
• Status Verified: 2021-04
• Study Start: 2021-04-20
• Study First Submitted QC: 2021-04-22
• Last Update Submitted: 2021-04-22
• Study First Posted: 2021-04-27
• Last Update Posted: 2021-04-27
• Primary Completion: 2022-11-20
• Study Completion: 2022-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Detailed echocardiographic examination	1.5 year	Detailed echocardiography using Phillips Envisor C according to the guidelines of the American society of echocardiography(18)،focusing on follow up of left ventricle end diastolic dimension Z-score ,left ventricle fractional shortening and ejection fraction.