Back to resultsTo Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Flecainide controlled release
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Tambocor, Paroxysmal Atrial Fibrillation, Quality of Life
Eligibility 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
Sites / Locations
- Hopital Cardiologique, Service de Cardiologique CHR de Lille
Outcomes
Primary Outcome Measures
To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
Secondary Outcome Measures
assessment of treatment success based on an efficacy/safety composite criterion;
assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
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).
Full Information
NCT ID
NCT00189319
First Posted
September 13, 2005
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00189319
Brief Title
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
Official Title
Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
MEDA Pharma GmbH & Co. KG
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Tambocor, Paroxysmal Atrial Fibrillation, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Flecainide controlled release
Primary Outcome Measure Information:
Title
To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
Secondary Outcome Measure Information:
Title
assessment of treatment success based on an efficacy/safety composite criterion;
Title
assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
Title
assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
Title
assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salem Kacet
Organizational Affiliation
Hopital Cardiologique, CHR de Lille, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Cardiologique, Service de Cardiologique CHR de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
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