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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

76

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Dronedarone
Dronedarone 400 mg twice a day
Legemiddel: Dronedarone

Filmdrasjert tablett

Oral administrering under matforhold (under frokost og middag)

Andre navn:
  • Multaq®
  • SR33589
Placebo komparator: Placebo
Placebo (for Dronedarone) twice a day
Legemiddel: Placebo (for Dronedarone)

filmdrasjert tablett er strengt identisk i utseende

Oral administrering under matforhold (under frokost og middag)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sanofi

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2010

Primær fullføring (Faktiske)

1. januar 2012

Studiet fullført (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først innsendt

9. september 2010

Først innsendt som oppfylte QC-kriteriene

9. september 2010

Først lagt ut (Anslag)

10. september 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. februar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DRONE_L_04315

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