Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement (ODYSSEUS)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Ontario
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Cambridge, Ontario, Canada
- Investigational Site Number 124003
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Investigational Site Number 840072
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Arkansas
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Little Rock, Arkansas, Stati Uniti, 72204
- Investigational Site Number 840015
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California
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Beverly Hills, California, Stati Uniti, 90211
- Investigational Site Number 840086
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Loma Linda, California, Stati Uniti, 92354
- Investigational Site Number 840018
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Merced, California, Stati Uniti, 95348
- Investigational Site Number 840029
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Redwood City, California, Stati Uniti, 94062
- Investigational Site Number 840044
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Santa Ana, California, Stati Uniti, 92704
- Investigational Site Number 840042
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Vista, California, Stati Uniti, 92083
- Investigational Site Number 840060
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Connecticut
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Stamford, Connecticut, Stati Uniti, 06905
- Investigational Site Number 840057
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Delaware
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Newark, Delaware, Stati Uniti, 19713
- Investigational Site Number 840002
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Wilmington, Delaware, Stati Uniti, 19808
- Investigational Site Number 840063
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Florida
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Bradenton, Florida, Stati Uniti, 34205
- Investigational Site Number 840070
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Jacksonville, Florida, Stati Uniti, 32216
- Investigational Site Number 840010
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Jupiter, Florida, Stati Uniti, 33458
- Investigational Site Number 840071
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Lakeland, Florida, Stati Uniti, 33805
- Investigational Site Number 840061
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Lauderdale Lakes, Florida, Stati Uniti, 33313
- Investigational Site Number 840096
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Ocala, Florida, Stati Uniti, 34471
- Investigational Site Number 840031
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Orlando, Florida, Stati Uniti, 32803
- Investigational Site Number 840074
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Ormond Beach, Florida, Stati Uniti, 32174
- Investigational Site Number 840016
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St Petersburg, Florida, Stati Uniti, 33709
- Investigational Site Number 840051
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Georgia
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Roswell, Georgia, Stati Uniti, 30076
- Investigational Site Number 840081
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Illinois
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Jerseyville, Illinois, Stati Uniti, 62052
- Investigational Site Number 840103
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Peoria, Illinois, Stati Uniti, 61606
- Investigational Site Number 840106
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Indiana
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Elkhart, Indiana, Stati Uniti, 46514
- Investigational Site Number 840066
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40504
- Investigational Site Number 840099
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Owensboro, Kentucky, Stati Uniti, 42303
- Investigational Site Number 840039
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Louisiana
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Baton Rouge, Louisiana, Stati Uniti, 70808
- Investigational Site Number 840092
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Maine
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Auburn, Maine, Stati Uniti, 04210
- Investigational Site Number 840040
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Massachusetts
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Ayer, Massachusetts, Stati Uniti, 01432
- Investigational Site Number 840077
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Michigan
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Alpena, Michigan, Stati Uniti, 49707
- Investigational Site Number 840050
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Saginaw, Michigan, Stati Uniti, 48670
- Investigational Site Number 840041
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55422
- Investigational Site Number 840058
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Mississippi
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Picayune, Mississippi, Stati Uniti, 39466
- Investigational Site Number 840101
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Missouri
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St Louis, Missouri, Stati Uniti, 63122
- Investigational Site Number 840078
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St Louis, Missouri, Stati Uniti, 63128
- Investigational Site Number 840038
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St. Louis, Missouri, Stati Uniti, 63128
- Investigational Site Number 840102
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Montana
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Kalispell, Montana, Stati Uniti, 59901
- Investigational Site Number 840012
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68506
- Investigational Site Number 840090
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New York
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Bronx, New York, Stati Uniti, 10468
- Investigational Site Number 840003
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Buffalo, New York, Stati Uniti, 14215
- Investigational Site Number 840045
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Manhasset, New York, Stati Uniti, 11030
- Investigational Site Number 840055
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Troy, New York, Stati Uniti, 12180
- Investigational Site Number 840004
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Ohio
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Maumee, Ohio, Stati Uniti, 43537
- Investigational Site Number 840009
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Pennsylvania
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Camp Hill, Pennsylvania, Stati Uniti, 17011
- Investigational Site Number 840028
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Wyomissing, Pennsylvania, Stati Uniti, 19610
- Investigational Site Number 840067
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Rhode Island
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Wakefield, Rhode Island, Stati Uniti, 02879
- Investigational Site Number 840027
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37917
- Investigational Site Number 840046
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Texas
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Longview, Texas, Stati Uniti, 75605
- Investigational Site Number 840014
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Virginia
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Danville, Virginia, Stati Uniti, 24541
- Investigational Site Number 840068
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Manassas, Virginia, Stati Uniti, 20109
- Investigational Site Number 840069
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Richmond, Virginia, Stati Uniti, 23249
- Investigational Site Number 840087
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Winchester, Virginia, Stati Uniti, 22601
- Investigational Site Number 840085
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Washington
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Burien, Washington, Stati Uniti, 98166
- Investigational Site Number 840013
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Spokane, Washington, Stati Uniti, 99204
- Investigational Site Number 840091
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53713
- Investigational Site Number 840080
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Milwaukee, Wisconsin, Stati Uniti, 53215
- Investigational Site Number 840023
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Dronedarone
Dronedarone 400 mg twice a day
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Compressa rivestita con film Somministrazione orale a stomaco pieno (durante la colazione e la cena)
Altri nomi:
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Comparatore placebo: Placebo
Placebo (for Dronedarone) twice a day
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compressa rivestita con film rigorosamente identica nell'aspetto Somministrazione orale a stomaco pieno (durante la colazione e la cena) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in Left Atrial Volume Index (LAVi)
Lasso di tempo: baseline (before randomization) and post-baseline (after 3-12 months of treatment)
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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)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes From Baseline in Left Atrial Function
Lasso di tempo: 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)
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Changes From Baseline in Left Atrial Dimension
Lasso di tempo: baseline (before randomization) and post-baseline (after 3-12 months of treatment)
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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)
|
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Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)
Lasso di tempo: 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)
|
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Changes From Baseline in Left Ventricular Function
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DRONE_L_04315
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