Using Flecainide to Treat Atrial Fibrillation
Can Global Peak Longitudinal Strain Measurements in Combination With Non-invasive ECG Parameters Predict the Success or Failure of Flecainide Treatment for Atrial Fibrillation Patients?
This study is testing if the heart medication flecainide can safely help people with atrial fibrillation maintain a normal heart rhythm over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Helsingborg, Skane) |
| Trial ID | NCT05084495 on ClinicalTrials.gov |
What this trial studies
This prospective observational study aims to evaluate the effectiveness and safety of flecainide in patients with atrial fibrillation who are eligible for this treatment. Participants will be monitored over a 12-month period with four clinical visits, during which clinical data, advanced echocardiographic data, and ECGs will be collected. The study will analyze outcomes such as maintaining normal sinus rhythm, the number of AF-free months, successful electrical cardioversion, side effects, and mortality. The goal is to improve the use of flecainide by addressing the current 'trial and error' approach in its administration.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with atrial fibrillation who are eligible for flecainide treatment.
Not a fit: Patients with atrial fibrillation who are not eligible for flecainide treatment or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer use of flecainide for patients with atrial fibrillation.
How similar studies have performed: While the use of flecainide in atrial fibrillation has been explored, this specific observational approach focusing on detailed echocardiographic analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with written informed consent who are eligible for flecainide treatment for atrial fibrillation. * The patients must be followed at the Skånes hospitals northwest and Skånes university hospitals. * Age \>18 years Exclusion Criteria: * Flecainide treatment with other indication than atrial fibrillation (including atrial flutter). * No secure date for treatment start. * Age \<18 years
Where this trial is running
Helsingborg, Skane
- Clinical Sciences, Helsingborg Medical Faculty Lund University — Helsingborg, Skane, Sweden (Recruiting)
Study contacts
- Principal investigator: Bjarne Madsen Härdig, RN, PhD — Lund University and Region Skane
- Study coordinator: Bjarne Madsen Härdig, RN, PhD
- Email: bjarne.madsen_hardig@med.lu.se
- Phone: +46 42 4061613
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.