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Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement (ODYSSEUS)

10. januar 2013 opdateret af: Sanofi

A Placebo-Controlled, Double-Blind, Randomized, Multi-center Study to Assess the Effects of Dronedarone 400 mg BID on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement

Primary Objective:

- Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment.

Secondary Objectives:

  • Evaluate the effects of dronedarone versus placebo on left atrial function;
  • Evaluate the effects of dronedarone versus placebo on left atrial dimension;
  • Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF, E, E', A, E/E')
  • Evaluate the safety and tolerability of dronedarone.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The planned total study period per participant was 12 months and 3 weeks broken down as follows:

  • Screening period: up to 1 week;
  • Treatment period: 12 months;
  • Follow-up period: 2 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Cambridge, Ontario, Canada
        • Investigational Site Number 124003
  • Forenede Stater
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85006
        • Investigational Site Number 840072
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72204
        • Investigational Site Number 840015
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Investigational Site Number 840086
      • Loma Linda, California, Forenede Stater, 92354
        • Investigational Site Number 840018
      • Merced, California, Forenede Stater, 95348
        • Investigational Site Number 840029
      • Redwood City, California, Forenede Stater, 94062
        • Investigational Site Number 840044
      • Santa Ana, California, Forenede Stater, 92704
        • Investigational Site Number 840042
      • Vista, California, Forenede Stater, 92083
        • Investigational Site Number 840060
    • Connecticut
      • Stamford, Connecticut, Forenede Stater, 06905
        • Investigational Site Number 840057
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Investigational Site Number 840002
      • Wilmington, Delaware, Forenede Stater, 19808
        • Investigational Site Number 840063
    • Florida
      • Bradenton, Florida, Forenede Stater, 34205
        • Investigational Site Number 840070
      • Jacksonville, Florida, Forenede Stater, 32216
        • Investigational Site Number 840010
      • Jupiter, Florida, Forenede Stater, 33458
        • Investigational Site Number 840071
      • Lakeland, Florida, Forenede Stater, 33805
        • Investigational Site Number 840061
      • Lauderdale Lakes, Florida, Forenede Stater, 33313
        • Investigational Site Number 840096
      • Ocala, Florida, Forenede Stater, 34471
        • Investigational Site Number 840031
      • Orlando, Florida, Forenede Stater, 32803
        • Investigational Site Number 840074
      • Ormond Beach, Florida, Forenede Stater, 32174
        • Investigational Site Number 840016
      • St Petersburg, Florida, Forenede Stater, 33709
        • Investigational Site Number 840051
    • Georgia
      • Roswell, Georgia, Forenede Stater, 30076
        • Investigational Site Number 840081
    • Illinois
      • Jerseyville, Illinois, Forenede Stater, 62052
        • Investigational Site Number 840103
      • Peoria, Illinois, Forenede Stater, 61606
        • Investigational Site Number 840106
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46514
        • Investigational Site Number 840066
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40504
        • Investigational Site Number 840099
      • Owensboro, Kentucky, Forenede Stater, 42303
        • Investigational Site Number 840039
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Investigational Site Number 840092
    • Maine
      • Auburn, Maine, Forenede Stater, 04210
        • Investigational Site Number 840040
    • Massachusetts
      • Ayer, Massachusetts, Forenede Stater, 01432
        • Investigational Site Number 840077
    • Michigan
      • Alpena, Michigan, Forenede Stater, 49707
        • Investigational Site Number 840050
      • Saginaw, Michigan, Forenede Stater, 48670
        • Investigational Site Number 840041
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55422
        • Investigational Site Number 840058
    • Mississippi
      • Picayune, Mississippi, Forenede Stater, 39466
        • Investigational Site Number 840101
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63122
        • Investigational Site Number 840078
      • St Louis, Missouri, Forenede Stater, 63128
        • Investigational Site Number 840038
      • St. Louis, Missouri, Forenede Stater, 63128
        • Investigational Site Number 840102
    • Montana
      • Kalispell, Montana, Forenede Stater, 59901
        • Investigational Site Number 840012
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68506
        • Investigational Site Number 840090
    • New York
      • Bronx, New York, Forenede Stater, 10468
        • Investigational Site Number 840003
      • Buffalo, New York, Forenede Stater, 14215
        • Investigational Site Number 840045
      • Manhasset, New York, Forenede Stater, 11030
        • Investigational Site Number 840055
      • Troy, New York, Forenede Stater, 12180
        • Investigational Site Number 840004
    • Ohio
      • Maumee, Ohio, Forenede Stater, 43537
        • Investigational Site Number 840009
    • Pennsylvania
      • Camp Hill, Pennsylvania, Forenede Stater, 17011
        • Investigational Site Number 840028
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • Investigational Site Number 840067
    • Rhode Island
      • Wakefield, Rhode Island, Forenede Stater, 02879
        • Investigational Site Number 840027
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37917
        • Investigational Site Number 840046
    • Texas
      • Longview, Texas, Forenede Stater, 75605
        • Investigational Site Number 840014
    • Virginia
      • Danville, Virginia, Forenede Stater, 24541
        • Investigational Site Number 840068
      • Manassas, Virginia, Forenede Stater, 20109
        • Investigational Site Number 840069
      • Richmond, Virginia, Forenede Stater, 23249
        • Investigational Site Number 840087
      • Winchester, Virginia, Forenede Stater, 22601
        • Investigational Site Number 840085
    • Washington
      • Burien, Washington, Forenede Stater, 98166
        • Investigational Site Number 840013
      • Spokane, Washington, Forenede Stater, 99204
        • Investigational Site Number 840091
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53713
        • Investigational Site Number 840080
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Investigational Site Number 840023

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

  • Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization;
  • Nonpermanent AF or AF/Atrial Flutter (AFL) documented electrocardiographically by both AF (or AF/AFL) and sinus rhythm within the prior 12 months;
  • At screening, sinus rhythm and Left Atrial Volume index (LAVi) ≥32 mL/m2 based on 2D-echocardiography;
  • At least one of the following cardiovascular (CV) risk factors: Age >70 years at start of screening, hypertension, diabetes mellitus, prior CV accident (stroke or transient ischemic attack) or systemic embolism, or left ventricular ejection fraction <0.40.

Exclusion criteria:

  • Permanent AF defined as continuous AF for 6 months or longer;
  • Persistent AF defined as sustained AF >7 days duration and/or requiring cardioversion in the 4 weeks before screening;
  • Prior valvular heart surgery or significant valvular heart disease including rheumatic heart disease or acquired valvular heart disease;
  • Aortic or mitral regurgitation greater than mild (>1+) or any degree of mitral stenosis at the screening echocardiogram;
  • Myocardial infarction within the 6 months prior to screening or stroke within 2 months prior to screening;
  • Pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy devices placed within the 6 months prior to screening or at anytime during the study;
  • Ongoing potentially dangerous symptoms when in AF/AFL such as angina pectoris, transient ischemic attacks, stroke, syncope as judged by the Investigator;
  • Cardiac ablative procedure or cardiac surgery within 3 months prior to screening, or percutaneous coronary intervention within 4 weeks prior to screening;

  • Need for concomitant medication that is prohibited in this trial, and would preclude the use of the study drug during the planned study period including the following:

    • Antiarrhythmics (eg, amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol);
    • Drugs or products that are strong inhibitors of CYP3A (eg, ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, ritonavir, and grapefruit juice);
    • Drugs that are inducers of CYP3A (eg, rifampin, phenobarbital, carbamazepine, phenytoin, and St John's wort);
  • QTc Bazett interval ≥500 msec on the screening ECG;
  • Bradycardia <50 bpm and/or PR interval ≥0.28 sec on the screening ECG unless the patient has a functional pacemaker;
  • New York Heart Association (NYHA) Class IV heart failure or NYHA Class II or III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic within 4 weeks prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dronedarone
Dronedarone 400 mg twice a day
Medicin: Dronedarone

Filmovertrukket tablet

Oral administration under fodrede forhold (under morgenmad og aftensmad)

Andre navne:
  • Multaq®
  • SR33589
Placebo komparator: Placebo
Placebo (for Dronedarone) twice a day
Medicin: Placebo (til Dronedarone)

filmovertrukket tablet er fuldstændig identisk i udseende

Oral administration under fodrede forhold (under morgenmad og aftensmad)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Left Atrial Volume Index (LAVi)
Tidsramme: baseline (before randomization) and post-baseline (after 3-12 months of treatment)

Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.

Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
baseline (before randomization) and post-baseline (after 3-12 months of treatment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes From Baseline in Left Atrial Function
Tidsramme: baseline (before randomization) and post-baseline (after 3-12 months of treatment)

left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.

Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
baseline (before randomization) and post-baseline (after 3-12 months of treatment)
Changes From Baseline in Left Atrial Dimension
Tidsramme: baseline (before randomization) and post-baseline (after 3-12 months of treatment)

Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.

Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis.
baseline (before randomization) and post-baseline (after 3-12 months of treatment)
Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)
Tidsramme: baseline (before randomization) and post-baseline (after 3-12 months of treatment)

Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.

Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis.
baseline (before randomization) and post-baseline (after 3-12 months of treatment)
Changes From Baseline in Left Ventricular Function
Tidsramme: baseline (before randomization) and post-baseline (after 3-12 months of treatment)

left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab.

Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
baseline (before randomization) and post-baseline (after 3-12 months of treatment)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2010

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

9. september 2010

Først indsendt, der opfyldte QC-kriterier

9. september 2010

Først opslået (Skøn)

10. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. februar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DRONE_L_04315

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Atrieflimren

Kliniske forsøg med Dronedarone

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mexico

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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