Efficacy and Safety Study of F373280

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Pierre Fabre Medicament
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01831856
First received: April 11, 2013
Last updated: January 20, 2014
Last verified: November 2013
  Purpose

The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal cardiac rhythm after direct electric cardioversion in patients with persistent atrial fibrillation and cardiac failure.


Condition Intervention Phase
Atrial Fibrillation
Drug: 1g of F373280
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of F373280 for Maintenance of Sinus Rhythm After Electrical Cardioversion in Patients With Persistent Atrial Fibrillation and Chronic Heart Failure. International, Multicentric, Randomised, Double-blind, Placebo Controlled Study.

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • First Atrial Fibrillation recurrence [ Time Frame: Up to 20 weeks after electrical cardioversion ] [ Designated as safety issue: No ]
    Time to first Atrial Fibrillation recurrence defined by the first episode of Atrial Fibrillation lasting for at least 10 minutes


Estimated Enrollment: 152
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: F373280 Drug: 1g of F373280
Oral administration, one capsule each evening with dinner.
Placebo Comparator: Placebo Drug: Placebo
Oral administration, one capsule each evening with dinner.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged more than 18 years (inclusive),
  • Patients with persistent Atrial Fibrillation between 7 days and 6 months duration for whom electrical cardioversion is warranted.
  • History of ischemic or non ischemic heart failure
  • On appropriate, stable medical treatments for heart failure, including a diuretic and/or angiotensin-converting enzyme, and/or angiotensin-receptor blocker and/or mineralocorticoid receptor (MR) antagonists, and/or betablockers
  • Patients treated or having to be treated by anti-vitamin K

Exclusion Criteria:

  • More than two successful cardioversions (electrical or pharmacological) in the last 6 months
  • Secondary Atrial Fibrillation due to alcohol or severe valvular heart disease (grade III to IV)
  • Thyroid disease uncontrolled by treatment
  • Myocardial infarction or unstable angina or presence of unstable ischemic coronaropathy assessed by coronarography or cardiac stress test within 6 months before selection
  • Severe chronic kidney disease at selection
  • Bradycardia
  • Hyperkalemia or hypokalemia at selection
  • Cardiac surgery within 3 months before selection or planned during the study duration
  • Previously ineffective pharmacological or electrical cardioversion
  • Concomitant treatment with any anti-arrhythmic drug (within 7 days prior to selection), except stable dose of digoxin, betablockers, calcium-blockers
  • Patient requiring a cardiac resynchronization therapy (CRT) or having undergone CRT implantation within the last 6 months
  • Treatment with any Polyunsaturated Fatty Acid (PUFA) within the last 3 months
  • Dietary supplement with ω3 or ω6 according to investigator's judgement
  • Having undergone any form of ablation therapy for Atrial Fibrillation
  • Patient treated with other anticoagulant treatment than antivitamin K: thrombin inhibitor such as Dabigatran or treated with antiaggregant P2Y12 inhibitors such as Clopidogrel or Prasugrel
  • Patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion
  • Breast-feeding female patient
  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: NCT01831856

Contacts
Contact: Pierre FABRE MEDICAMENT contact_cop@pierre-fabre.com

Locations
Czech Republic
Not yet recruiting
Hradec Králové, Czech Republic
Not yet recruiting
Karlovy Vary, Czech Republic
Not yet recruiting
Prague, Czech Republic
Recruiting
Ústí nad Labem, Czech Republic
France
Recruiting
Brest, France
Recruiting
Clermont Ferrand, France
Recruiting
Paris, France
Recruiting
Rennes, France
Recruiting
Toulouse, France
Hungary
Recruiting
Budapest, Hungary
Italy
Not yet recruiting
Ascoli Piceno, Italy
Not yet recruiting
Augusta, Italy
Not yet recruiting
Bari, Italy
Recruiting
Brescia, Italy
Not yet recruiting
Foggia, Italy
Not yet recruiting
Napoli, Italy
Not yet recruiting
Terni, Italy
Not yet recruiting
Verona, Italy
Poland
Recruiting
Grodzisk Mazowiecki, Poland
Recruiting
Radom, Poland
Recruiting
Warszawa, Poland
Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Recruiting
Santiago de Compostela, Spain
Recruiting
Tarragona, Spain
Recruiting
Valencia, Spain
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01831856     History of Changes
Other Study ID Numbers: F373280 CA 2 01, 2012-003487-48
Study First Received: April 11, 2013
Last Updated: January 20, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Italy: National Bioethics Committee
Italy: The Italian Medicines Agency
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Spain: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Hungary: Institutional Ethics Committee
Hungary: Ministry of Health, Social and Family Affairs
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration

Keywords provided by Pierre Fabre Medicament:
Cardiovascular diseases
Chronic Heart Failure

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014