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

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05193838
• Collaborator: (none)
• Enrollment: 100
• Anticipated Duration (Months): 14

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dilated Cardiomyopathy	Drug: Allopurinol Tablet

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Allopurinol on Left Ventricular Function in Children With Dilated Cardiomyopathy
• Anticipated Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2006 Mar 27.

• Responsible Party: Ghada Seif-elnasr Mohamed, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05193838
• Other Study ID Numbers: Allopurinol
• First Posted: Jan 18, 2022
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated; Allopurinol

Study Results

No Results Posted as of Jan 18, 2022