Effect of Allopurinol on Left Ventricular Function in Children With Dilated Cardiomyopathy

January 12, 2022 updated by: Ghada Seif-elnasr Mohamed, Assiut University
The aim of this study is to detect effect of allopurinol supplementation in pediatric patients with dilated cardiomyopathy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

DCM as a serious cardiac disorder in which structural or functional abnormalities of the heart muscle can lead to substantial morbidity and mortality owing to complications such as heart failure and arrhythmia Among patients with heart failure (HF), elevated serum uric acid levels and increased oxidative stress have been associated with increased mortality, implicating xanthine oxidase as a possible therapeutic target Xanthine oxidase (XO), a superoxide-generating enzyme, is up regulated in animals (6,7) and in humans with heart failure. Acute administration of the XO inhibitor allopurinol improves the mechanical efficiency of the failing heart ), whereas oxygen consumption paradoxically decreases. Direct XO inhibition in cardiac muscle leads to increased force generation by the myofilaments at any given level of activator calcium(10).

Allopurinol, an inhibitor of xanthine oxidase, may be a novel therapeutic agent for HF. Allopurinol reduces uric acid levels, prevents acute gout, and acts as an anti oxidant, which could be beneficial among HF patients(5)

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

Inclusion Criteria:

1 - 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Allopurinol
we plan to follow up effect of Allopurinol on left ventricular function in children with dilated cardiomyopathy for 6 months
Drug: Allopurinol Tablet
examined patients with dilated cardiomyopathy will receive allopurinol for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference of echocardiography parameters and ejection fraction between DCM patients taking Allopurinol and patients not taking
Time Frame: 6 months
follow up of improvement of ejection fraction by echocardiography
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

July 1, 2023

Study Registration Dates

First Submitted

November 26, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (ACTUAL)

January 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Allopurinol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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