Studying how children process propafenone and propranolol for arrhythmia treatment
Population Pharmacokinetics of Propafenone and Propranolol in Children Patients
Shandong University · NCT05463614
This study looks at how children with arrhythmia process the medications propafenone and propranolol to help improve treatment guidelines for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Shandong University (other) |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT05463614 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the pharmacokinetics and pharmacodynamics of propafenone and propranolol in children with arrhythmia. Given the lack of established dosing guidelines for these medications in pediatric patients, the study will collect data on how these drugs are metabolized and their effects in this population. By analyzing this data, the researchers hope to improve treatment protocols for children requiring these medications.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 18 years or younger who are being treated with propafenone and propranolol.
Not a fit: Patients with abnormal hepatic and renal function, allergies to propafenone, or those unable to complete the research will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer dosing guidelines for treating arrhythmia in children.
How similar studies have performed: While there is limited information on similar studies, the approach of studying pharmacokinetics in pediatric populations is essential and has shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≤18years. Parental written consent to participate in the study. Patients treat with Propafenone and Propranolol Exclusion Criteria: * 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.
Where this trial is running
Shijiazhuang, Hebei
- Hebei province Children's Hospital — Shijiazhuang, Hebei, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arrhythmia