NCT04860921

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

November 17, 2020

Last Update Submit

April 22, 2021

Conditions

Zinc Deficiency

Keywords

Dilated cardiomopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Detailed echocardiographic examination

    1.5 year

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patiente between 1 and18 years with dilated cardiomypathy

You may qualify if:

  • children (1-18) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy

You may not qualify if:

  • patients with congenital heart diseases.
  • patients less than one year age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1161/CIRCULATIONAHA.106.174287. Epub 2006 Mar 27.

    PMID: 16567565BACKGROUND

Central Study Contacts

Safaa Ahmed

CONTACT

01096449446Safaa.20124126@med.au.edu.eg

Safaa Sholkamy

CONTACT

Safaasholkamy1000@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2020

First Posted

April 27, 2021

Study Start

April 20, 2021

Primary Completion

November 20, 2022

Study Completion

December 28, 2022

Last Updated

April 27, 2021

Record last verified: 2021-04