To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT00189319
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: MEDA Pharma GmbH & Co. KG
• Public title: To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
• Scientific title: Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
• Date of first enrolment: September 2003
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00189319
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Salem Kacet
• Affiliation: Hopital Cardiologique, CHR de Lille, France

Key inclusion & exclusion criteria

Inclusion Criteria:

- In sinus rhythm at treatment initiation

- Experienced symptomatic AF episodes

- Left ventricular ejection fraction of at least 40%

- Females of child bearing potential must be using reliable method of contraception

Exclusion Criteria:

- Intolerance and/or failure of previous therapy with flecainide immediate release

- Currently receiving >200mg/day flecainide immediate release

- Severe symptoms during episodes of arrhythmia

- History of other cardiac conditions/abnormalities

- Heart surgery within the last 2 months

- Renal failure

- Pregnant or lactating females

- Significant extra cardiac or systemic disease

- Abnormal electrolyte levels

- Receiving defined cardiac and/or other treatments



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: Flecainide controlled release

Primary Outcome(s)

To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).

Secondary Outcome(s)

assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;

evaluation of the course of the disease by the time to the first recurrence of a PAF episode and the subjective symptomatology (duration and severity of PAF episodes).

assessment of treatment success based on an efficacy/safety composite criterion;

assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;

assessment of the relationship between QoL changes and outcomes related to safety and efficacy;

Secondary ID(s)

1478-FLEC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors