Antiarrhythmic ToxicityNCT04863001
Use of Antiarrhythmic Drugs in Pediatrics
An observational study of Antiarrhythmic Toxicity, run by Assiut University.
Trial summary
This study aims to describe the use of Cardiovascular Drugs in Pediatrics Cardiology unit Assiut University. As regard : indications of use . proper dosage. proper management of side effects of their use. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Antiarrhythmic Toxicity
- What is being tested?
- Antiarrhythmic drug
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 1 Oct 2022
- 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 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 1- Patients' selection:- patients from 1 month age till 18 years on antiarrhythmic medications in Cardiology Unit Assiut University Hospital antiarrhytmic medications .
Who may be able to join
- All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years
Who cannot join
- ● Patients with diseases rather than arrhythmic cardiac diseases
Trial locations and contacts
No sites are listed yet.
Salah Eldin Ahmad contact
About this study
Official title: Adescriptive Study on the Use of Antiarrhythmic Drugs in Pediatrics Cardiology Unit Assiut University
This study aims to describe the use of Cardiovascular Drugs in Pediatrics Cardiology unit Assiut University. As regard :
- indications of use .
- proper dosage.
- proper management of side effects of their use.
Read the detailed description
Arrhythmias occur in children and adolescents with congenital heart disease as well as those with structurally normal hearts. Antiarrhythmic medications primarily affect the ion channels in cardiac myocytes that are responsible for generating currents that create the action potential.
By altering the activity of these ion channels, the action potential is changed in an attempt to reduce the likelihood of sustained arrhythmias. There is awide range of antiarrhysmic drugs used in treatment Antiarrhysmics are therefore divided into five classes
Class I: Antiarrhythmics that affect sodium channels (slow depolarization) Class II: Drugs that counteract the sympathetic nervous system, predominantly beta-blockers Class III: drugs that affect the potasium channels ( prolong repolarization) Class IV: Drugs that affect calcium channels (Calcium channel blockers) Class V: Vagotonic drugs (Digoxin) and other miscellaneous drugs
- Conditions
- Antiarrhythmic Toxicity
- Being tested
- Antiarrhythmic drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrhythmic drugDrug
all classes of antiarrhythmic drugs used in pediatrics cardiology unit assiut university
What is being measured
The primary outcome is the main question the study is designed to answer.
descripe the use of antiarrhythmic drugs in pediatrics
to asses the use of antiarrhythmic drugs in cardiology unit whether its used for proper indications matching with last guidelines or not to asses also dosage (gram per Kg of weight) of each drug used .and detrimine the side effects appear and its proper management.
- proper dosage.
- proper management of side effects of their use
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Oct 2022 (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 Antiarrhythmic ToxicityStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areej Tarek Mostafa mohamed makhlouf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863001
- Sponsor's protocol ID
- antiarrhythmic drugs in pediat
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Podrid PJ. Antiarrhythmic drug selection. Annu Rev Med. 1987;38:1-17. doi: 10.1146/annurev.me.38.020187.000245.
PubMed 3555284
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adescriptive Study on the Use of Antiarrhythmic Drugs in Pediatrics Cardiology Unit Assiut University
- ClinicalTrials.gov ID
- NCT04863001
- Acronym / sponsor ID
- antiarrhythmic drugs in pediat
- Conditions
- Antiarrhythmic Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 28 Apr 2021 (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.
This study aims to describe the use of Cardiovascular Drugs in Pediatrics Cardiology unit Assiut University. As regard :
- indications of use .
- proper dosage.
- proper management of side effects of their use.
Detailed description
Arrhythmias occur in children and adolescents with congenital heart disease as well as those with structurally normal hearts. Antiarrhythmic medications primarily affect the ion channels in cardiac myocytes that are responsible for generating currents that create the action potential.
By altering the activity of these ion channels, the action potential is changed in an attempt to reduce the likelihood of sustained arrhythmias. There is awide range of antiarrhysmic drugs used in treatment Antiarrhysmics are therefore divided into five classes
Class I: Antiarrhythmics that affect sodium channels (slow depolarization) Class II: Drugs that counteract the sympathetic nervous system, predominantly beta-blockers Class III: drugs that affect the potasium channels ( prolong repolarization) Class IV: Drugs that affect calcium channels (Calcium channel blockers) Class V: Vagotonic drugs (Digoxin) and other miscellaneous drugs
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 1- Patients' selection:- patients from 1 month age till 18 years on antiarrhythmic medications in Cardiology Unit Assiut University Hospital antiarrhytmic medications .
Key inclusion criteria (1 listed)
- All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years
Key exclusion criteria (1 listed)
- ● Patients with diseases rather than arrhythmic cardiac diseases
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 |
|---|---|---|
| Antiarrhythmic drugall classes of antiarrhythmic drugs used in pediatrics cardiology unit assiut university | Drug | – |
Primary outcome
descripe the use of antiarrhythmic drugs in pediatrics
Time frame: one year
to asses the use of antiarrhythmic drugs in cardiology unit whether its used for proper indications matching with last guidelines or not to asses also dosage (gram per Kg of weight) of each drug used .and detrimine the side effects appear and its proper management. * proper dosage. * proper management of side effects of their use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 3555284Podrid PJ. Antiarrhythmic drug selection. Annu Rev Med. 1987;38:1-17. doi: 10.1146/annurev.me.38.020187.000245.
- Individual participant dataSharing planned: No
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.
Salah Eldin Ahmad contact
Questions about this trial
What is this clinical trial studying?
An observational study of Antiarrhythmic Toxicity, 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 1 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 6 May 2021. 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 Areej makhlouf (01001153846, areejmakhlouf2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descripe the use of antiarrhythmic drugs in pediatrics (time frame: one year). 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 NCT04863001, 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 6 May 2021.