Antiarrhythmic Drug Adverse ReactionNCT06272357
The Use of Antiarrhythmic Drugs in Pediatrics
An observational study of Antiarrhythmic Drug Adverse Reaction, run by Assiut University.
Trial summary
A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Antiarrhythmic Drug Adverse Reaction
- What is being tested?
- Antiarrhythmic drugs
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Mar 2025
- 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 30 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years.
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.
- All patient receiving antiarrhythmic drugs admitted to Assiut University Hospital for Children.
Who cannot join
- Any patient on drugs other than antiarrhythmics.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Audit on the Use of Antiarrhythmic Drugs in Pediatric Age Group
A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit
Read the detailed description
Arrhythmias occur in children and adolescents with congenital heart disease as well as those with structurally normal hearts.
Rhythm disturbances (arrhythmias) are not uncommon in sick children admitted in pediatric intensive care unit. These occur as a result of abnormalities in, or insults to, the cardiac conduction system or heart tissues. A rhythm disturbance in a child should be treated as life threatening emergency.
The generation of the action potential and the regional differences that are observed throughout the heart are the result of the selective permeability of ion channels distributed on the cell membrane.
Abnormalities in surface membrane ion channel function are central to arrhythmogenesis.
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 to reduce the likelihood of sustained arrhythmias.
These drugs are predominantly used in treatment of arrhythmia but in addition they are also used as a treatment of other cardiac and non-cardiac conditions.
For example, Calcium channel blockers have been one of the most widely used classes of antihypertensive agents in the last 20 years.
Carvedilol (a beta blocker agent) can be safely used for treatment of chronic heart dysfunction in pediatric patients with dilated cardiomyopathy.
β-blockers are also an essential component of pharmacologic therapy for children with congestive heart failure.
There is a wide range of antiarrhythmic drugs used in treatment of arrhythmias. The modernized comprehensive classification of both established and potential antiarrhythmic drugs was proposed in 2018 Class 0: HCN channel-mediated pacemaker current (If) block Class I: Antiarrhythmic that affect sodium channels (slow depolarization) Class II: Drugs that counteract the sympathetic nervous system, predominantly beta-blockers Class III: drugs that affect the potassium channels (prolong repolarization) Class IV: Drugs that affect calcium channels (Calcium channel blockers) Class V: mechanically sensitive ion channels, Mechanosensitive channel blockers Class VI: Gap junction channel blockers Class VII: Upstream target modulators.
In this study the aim is to describe the use of Cardiovascular Drugs in Pediatric Cardiology unit Assiut University. As regard: indications of use, proper dosage and proper management of side effects of their use.
- Conditions
- Antiarrhythmic Drug Adverse Reaction
- Being tested
- Antiarrhythmic drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiarrhythmic drugsOther
Antiarrhythmic drugs in pediatrics
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia.
A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital and the different indications for them other than the control of arrhythmia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiarrhythmic Drug Adverse ReactionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Abdel-Aziz mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272357
- Sponsor's protocol ID
- Antiarrhythmic drugs
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit on the Use of Antiarrhythmic Drugs in Pediatric Age Group
- ClinicalTrials.gov ID
- NCT06272357
- Acronym / sponsor ID
- Antiarrhythmic drugs
- Conditions
- Antiarrhythmic Drug Adverse Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Feb 2024 (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.
A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital, a clinical audit
Detailed description
Arrhythmias occur in children and adolescents with congenital heart disease as well as those with structurally normal hearts.
Rhythm disturbances (arrhythmias) are not uncommon in sick children admitted in pediatric intensive care unit. These occur as a result of abnormalities in, or insults to, the cardiac conduction system or heart tissues. A rhythm disturbance in a child should be treated as life threatening emergency.
The generation of the action potential and the regional differences that are observed throughout the heart are the result of the selective permeability of ion channels distributed on the cell membrane.
Abnormalities in surface membrane ion channel function are central to arrhythmogenesis.
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 to reduce the likelihood of sustained arrhythmias.
These drugs are predominantly used in treatment of arrhythmia but in addition they are also used as a treatment of other cardiac and non-cardiac conditions.
For example, Calcium channel blockers have been one of the most widely used classes of antihypertensive agents in the last 20 years.
Carvedilol (a beta blocker agent) can be safely used for treatment of chronic heart dysfunction in pediatric patients with dilated cardiomyopathy.
β-blockers are also an essential component of pharmacologic therapy for children with congestive heart failure.
There is a wide range of antiarrhythmic drugs used in treatment of arrhythmias. The modernized comprehensive classification of both established and potential antiarrhythmic drugs was proposed in 2018 Class 0: HCN channel-mediated pacemaker current (If) block Class I: Antiarrhythmic that affect sodium channels (slow depolarization) Class II: Drugs that counteract the sympathetic nervous system, predominantly beta-blockers Class III: drugs that affect the potassium channels (prolong repolarization) Class IV: Drugs that affect calcium channels (Calcium channel blockers) Class V: mechanically sensitive ion channels, Mechanosensitive channel blockers Class VI: Gap junction channel blockers Class VII: Upstream target modulators.
In this study the aim is to describe the use of Cardiovascular Drugs in Pediatric Cardiology unit Assiut University. As regard: indications of use, proper dosage and proper management of side effects of their use.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years.
Key inclusion criteria (2 listed)
- All Patients with Arrhythmic cardiac diseases admitted at cardiology unit Assiut University Hospital aged from 1 month to 18 years.
- All patient receiving antiarrhythmic drugs admitted to Assiut University Hospital for Children.
Key exclusion criteria (1 listed)
- Any patient on drugs other than antiarrhythmics.
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 drugsAntiarrhythmic drugs in pediatrics | Other | – |
Primary outcome
Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia.
Time frame: Baseline
A study on the use of antiarrhythmic drugs in pediatric age group, in Assiut University Children's Hospital and the different indications for them other than the control of arrhythmia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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 Antiarrhythmic Drug Adverse Reaction, 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 2 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 22 Feb 2024. 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 Reham Abdel-Aziz Mohamed, Resident doctor (+201098345222, rema31997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the rate of use of antiarrhythmic drugs in pediatrics and the different indications for them other than the control of arrhythmia. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2024.