Dilated CardiomyopathyNCT05193838
Effect of Allopurinol on Left Ventricular Function in Children With Dilated Cardiomyopathy
An observational study of Dilated Cardiomyopathy, run by Assiut University.
Trial summary
The aim of this study is to detect effect of allopurinol supplementation in pediatric patients with dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 1 year to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Allopurinol Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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
Who cannot join
- children with impaired left ventricular systolic function due to other causes like congenital heart diseases
- children with acquired heart diseases
- patients with allergic reaction or contra indicated from Allopurinol
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to detect effect of allopurinol supplementation in pediatric patients with dilated cardiomyopathy.
Read the 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
- Being tested
- Allopurinol Tablet
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allopurinol TabletDrug
examined patients with dilated cardiomyopathy will receive allopurinol for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | we plan to follow up effect of Allopurinol on left ventricular function in children with dilated cardiomyopathy for 6 months Receives: Drug: Allopurinol Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 May 2022 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Seif-elnasr Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193838
- Sponsor's protocol ID
- Allopurinol
- Status last verified
- Jan 2022
- First submitted
- 26 Nov 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. doi: 10.1161/CIRCULATIONAHA.106.174287. Epub 2006 Mar 27.
PubMed 16567565
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Allopurinol on Left Ventricular Function in Children With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05193838
- Acronym / sponsor ID
- Allopurinol
- Conditions
- Dilated Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | – | Drug: Allopurinol Tabletwe plan to follow up effect of Allopurinol on left ventricular function in children with dilated cardiomyopathy for 6 months |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- children with impaired left ventricular systolic function due to other causes like congenital heart diseases
- children with acquired heart diseases
- patients with allergic reaction or contra indicated from Allopurinol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allopurinol Tabletexamined patients with dilated cardiomyopathy will receive allopurinol for 6 months | Drug | Allopurinol |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Background: PubMed 16567565Maron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada seif elnasr mohamed, M.B.B.CH. (01030709367, Ghadaseifelnasr92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference of echocardiography parameters and ejection fraction between DCM patients taking Allopurinol and patients not taking (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05193838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.