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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Ontario
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Cambridge、Ontario、加拿大
- Investigational Site Number 124003
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Arizona
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Phoenix、Arizona、美国、85006
- Investigational Site Number 840072
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Arkansas
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Little Rock、Arkansas、美国、72204
- Investigational Site Number 840015
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California
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Beverly Hills、California、美国、90211
- Investigational Site Number 840086
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Loma Linda、California、美国、92354
- Investigational Site Number 840018
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Merced、California、美国、95348
- Investigational Site Number 840029
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Redwood City、California、美国、94062
- Investigational Site Number 840044
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Santa Ana、California、美国、92704
- Investigational Site Number 840042
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Vista、California、美国、92083
- Investigational Site Number 840060
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Connecticut
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Stamford、Connecticut、美国、06905
- Investigational Site Number 840057
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Delaware
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Newark、Delaware、美国、19713
- Investigational Site Number 840002
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Wilmington、Delaware、美国、19808
- Investigational Site Number 840063
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Florida
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Bradenton、Florida、美国、34205
- Investigational Site Number 840070
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Jacksonville、Florida、美国、32216
- Investigational Site Number 840010
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Jupiter、Florida、美国、33458
- Investigational Site Number 840071
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Lakeland、Florida、美国、33805
- Investigational Site Number 840061
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Lauderdale Lakes、Florida、美国、33313
- Investigational Site Number 840096
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Ocala、Florida、美国、34471
- Investigational Site Number 840031
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Orlando、Florida、美国、32803
- Investigational Site Number 840074
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Ormond Beach、Florida、美国、32174
- Investigational Site Number 840016
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St Petersburg、Florida、美国、33709
- Investigational Site Number 840051
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Georgia
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Roswell、Georgia、美国、30076
- Investigational Site Number 840081
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Illinois
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Jerseyville、Illinois、美国、62052
- Investigational Site Number 840103
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Peoria、Illinois、美国、61606
- Investigational Site Number 840106
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Indiana
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Elkhart、Indiana、美国、46514
- Investigational Site Number 840066
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Kentucky
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Lexington、Kentucky、美国、40504
- Investigational Site Number 840099
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Owensboro、Kentucky、美国、42303
- Investigational Site Number 840039
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Louisiana
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Baton Rouge、Louisiana、美国、70808
- Investigational Site Number 840092
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Maine
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Auburn、Maine、美国、04210
- Investigational Site Number 840040
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Massachusetts
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Ayer、Massachusetts、美国、01432
- Investigational Site Number 840077
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Michigan
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Alpena、Michigan、美国、49707
- Investigational Site Number 840050
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Saginaw、Michigan、美国、48670
- Investigational Site Number 840041
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Minnesota
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Minneapolis、Minnesota、美国、55422
- Investigational Site Number 840058
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Mississippi
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Picayune、Mississippi、美国、39466
- Investigational Site Number 840101
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Missouri
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St Louis、Missouri、美国、63122
- Investigational Site Number 840078
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St Louis、Missouri、美国、63128
- Investigational Site Number 840038
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St. Louis、Missouri、美国、63128
- Investigational Site Number 840102
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Montana
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Kalispell、Montana、美国、59901
- Investigational Site Number 840012
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Nebraska
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Lincoln、Nebraska、美国、68506
- Investigational Site Number 840090
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New York
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Bronx、New York、美国、10468
- Investigational Site Number 840003
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Buffalo、New York、美国、14215
- Investigational Site Number 840045
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Manhasset、New York、美国、11030
- Investigational Site Number 840055
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Troy、New York、美国、12180
- Investigational Site Number 840004
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Ohio
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Maumee、Ohio、美国、43537
- Investigational Site Number 840009
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Pennsylvania
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Camp Hill、Pennsylvania、美国、17011
- Investigational Site Number 840028
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Wyomissing、Pennsylvania、美国、19610
- Investigational Site Number 840067
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Rhode Island
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Wakefield、Rhode Island、美国、02879
- Investigational Site Number 840027
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Tennessee
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Knoxville、Tennessee、美国、37917
- Investigational Site Number 840046
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Texas
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Longview、Texas、美国、75605
- Investigational Site Number 840014
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Virginia
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Danville、Virginia、美国、24541
- Investigational Site Number 840068
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Manassas、Virginia、美国、20109
- Investigational Site Number 840069
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Richmond、Virginia、美国、23249
- Investigational Site Number 840087
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Winchester、Virginia、美国、22601
- Investigational Site Number 840085
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Washington
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Burien、Washington、美国、98166
- Investigational Site Number 840013
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Spokane、Washington、美国、99204
- Investigational Site Number 840091
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Wisconsin
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Madison、Wisconsin、美国、53713
- Investigational Site Number 840080
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Milwaukee、Wisconsin、美国、53215
- Investigational Site Number 840023
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dronedarone
Dronedarone 400 mg twice a day
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薄膜衣片 在进食条件下口服给药（早餐和晚餐期间）
其他名称：
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安慰剂比较：Placebo
Placebo (for Dronedarone) twice a day
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薄膜包衣片剂外观完全相同 在进食条件下口服给药（早餐和晚餐期间） |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Left Atrial Volume Index (LAVi)
大体时间：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)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes From Baseline in Left Atrial Function
大体时间：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
大体时间：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)
大体时间：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
大体时间：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)
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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