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

Atrial Fibrillation Clinical Trial

Official title:

Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189319
• Other study ID #: 1478-FLEC
• Status: Completed
• Phase: Phase 4
• Start date: September 2003

Study information

• Verified date: September 2006
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Flecainide controlled release

Locations

Country	Name	City	State
France	Hopital Cardiologique, Service de Cardiologique CHR de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
MEDA Pharma GmbH & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
Secondary	assessment of treatment success based on an efficacy/safety composite criterion;
Secondary	assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
Secondary	assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
Secondary	assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
Secondary	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).