Efficacy and Safety Study of F373280

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Pierre Fabre Medicament
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01831856
First received: April 11, 2013
Last updated: May 4, 2015
Last verified: May 2015
  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: April 2016
Estimated Primary Completion Date: April 2016 (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 current episode of persistent AF between 7 days and 6 months duration for whom electrical cardioversion is warranted
  • Previous history of first documented episode of persistent AF.
  • Previous history of ischemic or non ischemic heart failure
  • NYHA class I or II chronic heart failure at selection and at inclusion
  • Left ventricular systolic dysfunction defined at selection and at inclusion by a reduced left ventricular ejection fraction (LVEF) ≥ 30% and ≤ 45% or for patients with a LVEF > 45%:

    • an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or > 32 mm/m² and/or volume > 97 ml/m²)
    • and/or an increased left ventricular end-systolic size (diameter > 45 mm and/or > 25 mm/m² and/or volume > 43 ml/m²)
    • and/or a reduced left ventricular outflow tract velocity time integral < 15 cm
  • 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
  • Left atrial area ≤ 40 cm² at selection and at inclusion
  • Patients treated or having to be treated by vitamin K antagonist
  • For female patient of child-bearing potential:

    • In all the countries except Italy:
  • Use of an effective method of contraception (hormonal contraception or intra-uterine device) assessed by the investigator, for at least 2 months before the selection in the study, and agreement to go on using it during the whole duration of the study and up to 1 month after the last dose of the study treatment
  • Documented as surgically sterilized

    • In Italy only:
  • Absolute abstention from sexual intercourse during the whole duration of the study and for a month after the end of the study or
  • Use of double barrier contraception method (use of effective medical contraception method) from at least 2 months before the start of the study to the entire duration of the study and for a month after the end of the study or
  • Documented as surgically sterilized.
  • For female patient of child-bearing potential: negative urine pregnancy test at inclusion
  • For male with a child-bearing potential partner (In Italy only):
  • Absolute abstention from sexual intercourse during the whole duration of the study and for 3 months after the end of the study or
  • Use of double barrier contraception method (use of condom for male and effective contraception method for the partner) from the entire duration of the study to 3 months after the end of the study.

Ethical / legal considerations:

  • Having signed his/her written informed consent,
  • Affiliated to a social security system, or is beneficiary (if applicable in the national regulation)

Exclusion Criteria:

  • No previous history of first documented episode of persistent AF
  • 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)
  • NYHA class III or IV heart failure at selection or at inclusion
  • Thyroid disease uncontrolled by treatment: TSH ± T4L ± T3L to be checked in case of treatment for thyroid disease
  • Myocardial infarction or unstable angina or presence of unstable ischemic coronaropathy assessed by coronarography or cardiac stress test (Echo stress, exercise stress test, nuclear or MR perfusion evaluation methods) within 6 months before selection
  • Severe chronic kidney disease (creatinine ≥ 25 mg/L or estimated glomerular filtration rate < 30 ml/min) at selection
  • Bradycardia (HR ≤ 50 bpm)
  • Hyperkalemia or hypokalemia (according to the standards of local laboratories) at selection
  • Cardiac surgery within 3 months before selection or planned during the study duration

Criteria related to treatments:

  • Previously ineffective pharmacological or electrical cardioversion
  • Concomitant treatment with ranolazine or any antiarrhythmic drug (within 7 days prior to selection), except amiodarone, dronedarone and stable dose of digoxin, betablockers, calcium-blockers
  • Concomitant treatment with oral amiodarone or dronedarone from selection
  • Concomitant treatment with intravenous amiodarone from selection
  • 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 ω 3 or ω 6 according to investigator's judgement
  • Having undergone any form of ablation therapy for AF
  • Patient treated with oral anticoagulant treatment other than vitamin K antagonist: new oral anticoagulants (dabigatran, rivaroxaban, apixaban), or treated with irreversible antiplatelet agents P2Y12 inhibitors such as ticlopidine, clopidogrel or prasugrel

Other criteria:

  • Patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion
  • Patient having taken part in a clinical trial in the preceding 2 months or taking part in a trial at the time of selection
  • Patient linguistically or mentally unable to understand the nature, objectives and possible consequences of the trial, or refusing to patient himself/herself to its constraints
  • Patient family member or work associate (secretary, nurse, technician,..) of the Investigator
  • Patient having forfeited his / her freedom by administrative or legal award or being under guardianship
  • Breastfeeding 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
Recruiting
Hradec Králové, Czech Republic
Recruiting
Karlovy Vary, Czech Republic
Recruiting
Prague, Czech Republic
Recruiting
Ústí nad Labem, Czech Republic
France
Terminated
Brest, France
Terminated
Clermont Ferrand, France
Terminated
Paris, France
Terminated
Rennes, France
Terminated
Toulouse, France
Hungary
Recruiting
Budapest, Hungary
Italy
Terminated
Ascoli Piceno, Italy
Recruiting
Augusta, Italy
Recruiting
Brescia, Italy
Recruiting
Foggia, Italy
Terminated
Napoli, Italy
Recruiting
Terni, Italy
Recruiting
Verona, Italy
Poland
Terminated
Grodzisk Mazowiecki, Poland
Terminated
Radom, Poland
Recruiting
Sandomierz, Poland
Recruiting
Warszawa, Poland
Spain
Recruiting
Barcelona, Spain
Recruiting
Fuenlabrada, Spain
Recruiting
Madrid, Spain
Recruiting
Santiago de Compostela, Spain
Terminated
Tarragona, Spain
Terminated
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: May 4, 2015
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
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 29, 2015