Zinc Deficiency in Dilated Cardiomyopathy

Zinc Deficiency Clinical Trial

Official title:

Oral Zinc Supplementation in Children With Dilated Cardiomyopathy : Aprospective Cohort Study in Assiut ,Egypt.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04860921
• Other study ID #: Zinc in dilated cardiomyopathy
• Status: Not yet recruiting
• Start date: April 20, 2021
• Est. completion date: December 28, 2022

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: Safaa Ahmed
• Phone: 01096449446
• Email: Safaa.20124126[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 28, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Zinc Deficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Maron BJ, Towbin JA, Thiene G, Antzelevitch C, Corrado D, Arnett D, Moss AJ, Seidman CE, Young JB; American Heart Association; Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; Council on Epidemiology and Prevention. Contemporary definitions and classification of the cardiomyopathies: an American Heart Association Scientific Statement from the Council on Clinical Cardiology, Heart Failure and Transplantation Committee; Quality of Care and Outcomes Research and Functional Genomics and Translational Biology Interdisciplinary Working Groups; and Council on Epidemiology and Prevention. Circulation. 2006 Apr 11;113(14):1807-16. Epub 2006 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New york heart associaton functional classification for grading heart failure	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	1.5 year
Secondary	Detailed echocardiographic examination	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.	1.5 year