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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Dronedarone
Dronedarone 400 mg twice a day
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Comprimido revestido por película Administração oral em condições de alimentação (durante o café da manhã e jantar)
Outros nomes:
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Comparador de Placebo: Placebo
Placebo (for Dronedarone) twice a day
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comprimido revestido por película estritamente idêntico na aparência Administração oral em condições de alimentação (durante o café da manhã e jantar) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Left Atrial Volume Index (LAVi)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Changes From Baseline in Left Atrial Function
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DRONE_L_04315
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