ArrhythmiaNCT05463614
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
An observational study of Arrhythmia, run by Shandong University at 1 site in China.
Trial summary
The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Propafenone and Propranolol
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 1 Dec 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children aged 0-18 years and receive treatment with Propafenone and Propranolol
Who may be able to join
- Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol
Who cannot join
- Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei province Children's Hospital
Shijiazhuang, Hebei
wei Zhao, 0531-89268436, zhao4wei2@hotmail.com
About this study
The use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.
- Conditions
- Arrhythmia
- Being tested
- Propafenone and Propranolol
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propafenone and PropranololDrug
Propafenone Hydrochloride Tablets, 100-200mg, 1 or 2 times per day; Propranolol Hydrochloride Sustained-Release Capsules, 40mg, 1 times per day
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular premature beats of 24 hours
frequency of Ventricular premature beats of 24 hours
Measured: From date of randomization until the date of discharge, assessed up to 12 months
Secondary outcomes (2)
P-R interval
P-R interval time
Measured: From date of randomization until the date of discharge, assessed up to 12 months
QT interval
QT interval time
Measured: From date of randomization until the date of discharge, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Feb 2019
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463614
- Sponsor's protocol ID
- 2021_Cardiology Drugs_001
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
- ClinicalTrials.gov ID
- NCT05463614
- Acronym / sponsor ID
- 2021_Cardiology Drugs_001
- Conditions
- Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Jul 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 use of propafenone and propranolol in children during clinical treatment was depending mostly on experience. Besides, there was no recommended dose for children in drug instruction. Therefore, the investigators' aim is to study the pharmacokinetics and pharmacodynamics in children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children aged 0-18 years and receive treatment with Propafenone and Propranolol
Key inclusion criteria (1 listed)
- Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol
Key exclusion criteria (1 listed)
- Patients can not complete the research; Abnormal hepatic and renal function; Patient is allergic to propafenone; There are conditions that researchers do not consider it appropriate to join the research.
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 |
|---|---|---|
| Propafenone and PropranololPropafenone Hydrochloride Tablets, 100-200mg, 1 or 2 times per day; Propranolol Hydrochloride Sustained-Release Capsules, 40mg, 1 times per day | Drug | – |
Primary outcome
Ventricular premature beats of 24 hours
Time frame: From date of randomization until the date of discharge, assessed up to 12 months
frequency of Ventricular premature beats of 24 hours
2 secondary outcomes
P-R interval
Time frame: From date of randomization until the date of discharge, assessed up to 12 months
QT interval
Time frame: From date of randomization until the date of discharge, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia, run by Shandong University at 1 site in China.
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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular premature beats of 24 hours (time frame: From date of randomization until the date of discharge, assessed up to 12 months). 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 19 Jul 2022.