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

NCT ID: NCT05193838

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-07-31

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)

Conditions

Dilated Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Allopurinol

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

Allopurinol Tablet

Intervention Type: DRUG

examined patients with dilated cardiomyopathy will receive allopurinol for 6 months

Interventions

Allopurinol Tablet

examined patients with dilated cardiomyopathy will receive allopurinol for 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Seif-elnasr Mohamed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

Ghadaseifelnasr92@gmail.com

01030709367

Amr Mohamed kotb, MD

Role: CONTACT

amrkotb336@aun.edu.eg

01067211589

References

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.

Reference Type: BACKGROUND

PMID: 16567565 (View on PubMed)

Other Identifiers

Allopurinol

Identifier Type: -

Identifier Source: org_study_id