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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Cambridge, Ontario, Canadá
- Investigational Site Number 124003
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Investigational Site Number 840072
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72204
- Investigational Site Number 840015
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California
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Beverly Hills, California, Estados Unidos, 90211
- Investigational Site Number 840086
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Loma Linda, California, Estados Unidos, 92354
- Investigational Site Number 840018
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Merced, California, Estados Unidos, 95348
- Investigational Site Number 840029
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Redwood City, California, Estados Unidos, 94062
- Investigational Site Number 840044
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Santa Ana, California, Estados Unidos, 92704
- Investigational Site Number 840042
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Vista, California, Estados Unidos, 92083
- Investigational Site Number 840060
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Connecticut
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Stamford, Connecticut, Estados Unidos, 06905
- Investigational Site Number 840057
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- Investigational Site Number 840002
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Wilmington, Delaware, Estados Unidos, 19808
- Investigational Site Number 840063
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Florida
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Bradenton, Florida, Estados Unidos, 34205
- Investigational Site Number 840070
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Jacksonville, Florida, Estados Unidos, 32216
- Investigational Site Number 840010
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Jupiter, Florida, Estados Unidos, 33458
- Investigational Site Number 840071
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Lakeland, Florida, Estados Unidos, 33805
- Investigational Site Number 840061
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Lauderdale Lakes, Florida, Estados Unidos, 33313
- Investigational Site Number 840096
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Ocala, Florida, Estados Unidos, 34471
- Investigational Site Number 840031
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Orlando, Florida, Estados Unidos, 32803
- Investigational Site Number 840074
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Ormond Beach, Florida, Estados Unidos, 32174
- Investigational Site Number 840016
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St Petersburg, Florida, Estados Unidos, 33709
- Investigational Site Number 840051
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Georgia
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Roswell, Georgia, Estados Unidos, 30076
- Investigational Site Number 840081
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Illinois
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Jerseyville, Illinois, Estados Unidos, 62052
- Investigational Site Number 840103
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Peoria, Illinois, Estados Unidos, 61606
- Investigational Site Number 840106
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Indiana
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Elkhart, Indiana, Estados Unidos, 46514
- Investigational Site Number 840066
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40504
- Investigational Site Number 840099
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Owensboro, Kentucky, Estados Unidos, 42303
- Investigational Site Number 840039
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808
- Investigational Site Number 840092
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Maine
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Auburn, Maine, Estados Unidos, 04210
- Investigational Site Number 840040
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Massachusetts
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Ayer, Massachusetts, Estados Unidos, 01432
- Investigational Site Number 840077
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Michigan
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Alpena, Michigan, Estados Unidos, 49707
- Investigational Site Number 840050
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Saginaw, Michigan, Estados Unidos, 48670
- Investigational Site Number 840041
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55422
- Investigational Site Number 840058
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Mississippi
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Picayune, Mississippi, Estados Unidos, 39466
- Investigational Site Number 840101
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Missouri
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St Louis, Missouri, Estados Unidos, 63122
- Investigational Site Number 840078
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St Louis, Missouri, Estados Unidos, 63128
- Investigational Site Number 840038
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St. Louis, Missouri, Estados Unidos, 63128
- Investigational Site Number 840102
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Montana
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Kalispell, Montana, Estados Unidos, 59901
- Investigational Site Number 840012
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68506
- Investigational Site Number 840090
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New York
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Bronx, New York, Estados Unidos, 10468
- Investigational Site Number 840003
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Buffalo, New York, Estados Unidos, 14215
- Investigational Site Number 840045
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Manhasset, New York, Estados Unidos, 11030
- Investigational Site Number 840055
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Troy, New York, Estados Unidos, 12180
- Investigational Site Number 840004
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Ohio
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Maumee, Ohio, Estados Unidos, 43537
- Investigational Site Number 840009
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Pennsylvania
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Camp Hill, Pennsylvania, Estados Unidos, 17011
- Investigational Site Number 840028
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Wyomissing, Pennsylvania, Estados Unidos, 19610
- Investigational Site Number 840067
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Rhode Island
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Wakefield, Rhode Island, Estados Unidos, 02879
- Investigational Site Number 840027
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Tennessee
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Knoxville, Tennessee, Estados Unidos, 37917
- Investigational Site Number 840046
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Texas
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Longview, Texas, Estados Unidos, 75605
- Investigational Site Number 840014
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Virginia
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Danville, Virginia, Estados Unidos, 24541
- Investigational Site Number 840068
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Manassas, Virginia, Estados Unidos, 20109
- Investigational Site Number 840069
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Richmond, Virginia, Estados Unidos, 23249
- Investigational Site Number 840087
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Winchester, Virginia, Estados Unidos, 22601
- Investigational Site Number 840085
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Washington
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Burien, Washington, Estados Unidos, 98166
- Investigational Site Number 840013
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Spokane, Washington, Estados Unidos, 99204
- Investigational Site Number 840091
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53713
- Investigational Site Number 840080
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Milwaukee, Wisconsin, Estados Unidos, 53215
- Investigational Site Number 840023
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Dronedarone
Dronedarone 400 mg twice a day
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Comprimido recubierto con película Administración oral en condiciones de alimentación (durante el desayuno y la cena)
Otros nombres:
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Comparador de placebos: Placebo
Placebo (for Dronedarone) twice a day
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comprimido recubierto con película estrictamente idéntico en apariencia Administración oral en condiciones de alimentación (durante el desayuno y la cena) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Left Atrial Volume Index (LAVi)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes From Baseline in Left Atrial Function
Periodo de tiempo: baseline (before randomization) and post-baseline (after 3-12 months of treatment)
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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
Periodo de tiempo: 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)
Periodo de tiempo: baseline (before randomization) and post-baseline (after 3-12 months of treatment)
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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
Periodo de tiempo: 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)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DRONE_L_04315
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