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

• Conditions: Dilated Cardiomyopathy
• Interventions: Drug: Allopurinol Tablet

• Registration Number: NCT05193838
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-11-26
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-18
• Study Start: 2022-05-01
• Primary Completion: 2023-05
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
difference of echocardiography parameters and ejection fraction between DCM patients taking Allopurinol and patients not taking	6 months	follow up of improvement of ejection fraction by echocardiography