Skip to main content
Clinical Trials/NCT05084495
NCT05084495
Completed
Not Applicable

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?

Lund University1 site in 1 country50 target enrollmentFebruary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Lund University
Enrollment
50
Locations
1
Primary Endpoint
Arrythmia free health status
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

This prospective observational study will include patients with atrial fibrillation that has indication for treatement with flecainide. Included patients are followed during a 12 month period. During the follow-up period they will have four clinical visits, during which clinical data, advanced echocardiographic data (strain and speckle tracking) and ECGs (Glasgow criteria) will be collected. These data will be analysed in relation to outcome parameters as: maintaining a normal sinus rhythm (arrythmia free health status), number of AF-free months, chances of successful electrical cardioversion, frequency of side effects, risk of pro-arrhythmias and mortality. The importance of these two analyses is to improve the use of flecainide. Hence, today patients with low benefit compared to risk of adverse events are inappropriately treated with flecainide with the "trial and error" approach currently used. On the other hand flecainide is currently underutilized, and patients denied the treatment that could improve their quality of life, prognosis and reduce their risk of cardiovascular adverse events. By investigating novel and promising parameters there is the potential of a better prediction of initiating safe and accurate anti-arrhythmic therapy for patients with atrial fibrillation.

Detailed Description

Study synopsis for the Tambocor Prospective study Inclusion: Patients with atrial fibrillation that admitted to the ward for prior to start of flecainide initiation. Ethics: Informed Concent prior to inclusion. Follow up after baseline: 4 visits during 12 month. End points : Side effects that lead to discontinuation of flecainide. Persistent AF that lead to discontinuation of flecainide. Evaluated parameters: 12 lead ECG, ECHO: LA, LV, HV strain , Dynamic Heart model: LV and RV. The follow up visits: Baseline: Normal ECHO after the first dose of flecainide, ECG and Questionnaire 4 Weeks: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire. 6 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire. 12 month: Normal ECHO + Protocol ECHO (LA, LV, HV strain , Dynamic Heart model: LV and RV) and Questionnaire.

Registry
clinicaltrials.gov
Start Date
February 1, 2022
End Date
April 15, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Arrythmia free health status

Time Frame: During the 12 month follow up

Can we predict who will maintain a normal sinus rhythm prior to initiation of flecainide? treatment start

Secondary Outcomes

  • Frequency of side effects(During the 12 month follow up)
  • Number of AF-free months(During the 12 month follow up)
  • Risk of pro-arrhythmias(During the 12 month follow up)
  • Mortality(During the 12 month follow up)

Study Sites (1)

Loading locations...

Similar Trials