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

Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05193838
• Other study ID #: Allopurinol
• Status: Not yet recruiting
• Start date: May 1, 2022
• Est. completion date: July 2023

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: Ghada seif elnasr mohamed, M.B.B.CH.
• Phone: 01030709367
• Email: Ghadaseifelnasr92[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Drug:
• Allopurinol Tablet
examined patients with dilated cardiomyopathy will receive allopurinol for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. Epub 2006 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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