Clinical trial NCT04860921: Zinc Deficiency in Dilated Cardiomyopathy
Official title: Oral Zinc Supplementation in Children With Dilated Cardiomyopathy : Aprospective Cohort Study in Assiut ,Egypt.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Zinc Deficiency
Keywords: Dilated cardiomopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patiente between 1 and18 years with dilated cardiomypathy

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.

Eligibility criteria: 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.

Primary outcomes:
measure: New york heart associaton functional classification for grading heart failure
timeFrame: 1.5 year
Secondary outcomes:
measure: Detailed echocardiographic examination
timeFrame: 1.5 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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. doi: 10.1161/CIRCULATIONAHA.106.174287. Epub 2006 Mar 27.