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Atrial FibrillationPhase 2NCT01831856

Efficacy and Safety Study of F373280

A Phase 2 study testing 1g of F373280 in people with Atrial Fibrillation, run by Pierre Fabre Medicament at 20 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
1g of F373280
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
20 sitesin 5 countries
Study dates
Apr 2013to 21 Jun 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women aged more than 18 years (inclusive)
  • Patients with current episode of persistent Atrial Fibrillation (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
  • New York Heart Association (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%:
Show all 27Show fewer
  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

20 sites in 5 countries.

20 sites in 5 countries

Italy5 sites

  • Study site

    Augusta

  • Study site

    Brescia

  • Study site

    Foggia

  • Study site

    Terni

  • Study site

    Verona

Other trials in Italy

Hungary4 sites

  • Study site

    Budapest, 1023

  • Study site

    Budapest, 1032

  • Study site

    Budapest, 1096

  • Study site

    Budapest, 1122

Other trials in Hungary

Poland4 sites

  • Study site

    Grodzisk Mazowiecki

  • Study site

    Radom

  • Study site

    Sandomierz

  • Study site

    Warsaw, 03-242

Other trials in Poland

Spain4 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Santiago de Compostela

  • Study site

    Tarragona

Other trials in Spain

Czechia3 sites

  • Study site

    Karlovy Vary

  • Study site

    Prague, 128 08

  • Study site

    Praha 5 - Motol

Other trials in Czechia

About this study

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.

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.

Being tested
1g of F373280, Placebo
Keywords
Cardiovascular diseases, Chronic Heart Failure
Medical subject headings
Atrial Fibrillation, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1g of F373280Drug

    Oral administration, one capsule each evening with dinner.

  • PlaceboDrug

    Oral administration, one capsule each evening with dinner.

Study groups in NCT01831856
Study groupRoleWhat they receive
F373280ExperimentalNot described
Receives: Drug: 1g of F373280
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Atrial Fibrillation (AF) Recurrence or Atrial Flutter Emergence Defined by the Time to First Episode of AF or Atrial Flutter Lasting for at Least 10 Minutes During the 20-week Follow-up After Visit 3 (Electrical Cardioversion (ECV) Visit).

    Time to first Atrial Fibrillation (AF) recurrence defined by the first episode of Atrial Fibrillation lasting for at least 10 minutes. AF recurrences or atrial flutter emergences: 7-day continuous electrocardiogram (ECG; 5-leads/2 or 3 channels) ambulatory recording (Holter ECG) between Visit 3 (Electrical Cardioversion Visit) and Visit 4 (Week 5). Then, the follow-up was documented using the Transtelephonic ECG monitor (TTEM): one transmission every two days from Week 9 to Week 24. For randomised patients with spontaneous cardioversion before Electrical Cardioversion, the recurrence of AF or the emergence of atrial flutter was assessed after Visit 3 (from Week 5). Moreover, during this TTEM period, if the patient experienced any AF or atrial flutter symptoms, it was recorded and documented using the TTEM.

    Measured: from electrical cardioversion (Visit 3) to last follow-up visit (W24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completion3 Apr 2017
  4. Study completion21 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831856
Sponsor's protocol ID
F373280 CA 2 01
Other IDs
2012-003487-48
Status last verified
Jun 2019
First submitted
11 Apr 2013
Last updated
2 Jul 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 1g of F373280 in people with Atrial Fibrillation, run by Pierre Fabre Medicament at 20 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Italy, Hungary, Poland, Spain, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Atrial Fibrillation (AF) Recurrence or Atrial Flutter Emergence Defined by the Time to First Episode of AF or Atrial Flutter Lasting for at Least 10 Minutes During the 20-week Follow-up After Visit 3 (Electrical Cardioversion (ECV) Visit). (time frame: from electrical cardioversion (Visit 3) to last follow-up visit (W24)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.

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