NCT05463614

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3.5 years

First QC Date

July 8, 2022

Last Update Submit

July 17, 2022

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • Ventricular premature beats of 24 hours

    frequency of Ventricular premature beats of 24 hours

    From date of randomization until the date of discharge, assessed up to 12 months

Secondary Outcomes (2)

  • P-R interval

    From date of randomization until the date of discharge, assessed up to 12 months

  • QT interval

    From date of randomization until the date of discharge, assessed up to 12 months

Interventions

Propafenone and PropranololDRUG

Propafenone Hydrochloride Tablets, 100-200mg, 1 or 2 times per day; Propranolol Hydrochloride Sustained-Release Capsules, 40mg, 1 times per day

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

children aged 0-18 years and receive treatment with Propafenone and Propranolol

You may qualify if:

  • Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei province Children's Hospital

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

PropafenonePropranolol

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 19, 2022

Study Start

February 1, 2019

Primary Completion

August 1, 2022

Study Completion

December 1, 2025

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)