NCT05193838

Brief Summary

The aim of this study is to detect effect of allopurinol 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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

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 26, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

November 26, 2021

Last Update Submit

January 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • difference of echocardiography parameters and ejection fraction between DCM patients taking Allopurinol and patients not taking

    follow up of improvement of ejection fraction by echocardiography

    6 months

Study Arms (1)

Allopurinol

we plan to follow up effect of Allopurinol on left ventricular function in children with dilated cardiomyopathy for 6 months

Drug: Allopurinol Tablet

Interventions

examined patients with dilated cardiomyopathy will receive allopurinol for 6 months

Allopurinol

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

This study is a prospective cohort study, it will include 100 patient who attend pediatric cardiology unit or pediatric cardiology outpatient clinic in Assiut university children hospital in Assiut governate, Egypt

You may qualify if:

  • children (1-16) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy, who attend pediatric cardiology unit 2-children attend to pediatric cardiology out patient clinic in Assiut university children hospital 3-children with no allergic reaction from allopurinol

You may not qualify if:

  • children with impaired left ventricular systolic function due to other causes like congenital heart diseases
  • children with acquired heart diseases
  • patients with allergic reaction or contra indicated from Allopurinol

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

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Ghada seif elnasr mohamed, M.B.B.CH.

CONTACT

Amr Mohamed kotb, MD

CONTACT

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 26, 2021

First Posted

January 18, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

July 1, 2023

Last Updated

January 18, 2022

Record last verified: 2022-01