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

April 11, 2013
May 4, 2015
April 2013
April 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01831856 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety Study of F373280
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: 1g of F373280
    Oral administration, one capsule each evening with dinner.
  • Drug: Placebo
    Oral administration, one capsule each evening with dinner.
  • Experimental: F373280
    Intervention: Drug: 1g of F373280
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pierre FABRE MEDICAMENT contact_cop@pierre-fabre.com
Czech Republic,   France,   Hungary,   Italy,   Poland,   Spain
 
NCT01831856
F373280 CA 2 01, 2012-003487-48
Not Provided
Pierre Fabre Medicament
Pierre Fabre Medicament
Not Provided
Not Provided
Pierre Fabre Medicament
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP