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

Sponsor:	MEDA Pharma GmbH & Co. KG
Information provided by:	MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT00189319

Purpose

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

Condition	Intervention	Phase
Atrial Fibrillation	Drug: Flecainide controlled release	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Flecainide Flecainide acetate

U.S. FDA Resources

Further study details as provided by MEDA Pharma GmbH & Co. KG:

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).

Estimated Enrollment:	200
Study Start Date:	September 2003

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189319

Locations

France
Hopital Cardiologique, Service de Cardiologique CHR de Lille
Lille, France, 59037

Sponsors and Collaborators

MEDA Pharma GmbH & Co. KG

Investigators

Principal Investigator:

Salem Kacet

Hopital Cardiologique, CHR de Lille, France

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00189319 History of Changes
Other Study ID Numbers:	1478-FLEC
Study First Received:	September 13, 2005
Last Updated:	February 20, 2007
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by MEDA Pharma GmbH & Co. KG:

Tambocor
Paroxysmal Atrial Fibrillation
Quality of Life

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

Flecainide
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012