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

This study has been completed.
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00189319
First received: September 13, 2005
Last updated: February 20, 2007
Last verified: September 2006
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 July 22, 2014