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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85006
- Investigational Site Number 840072
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Arkansas
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Little Rock、Arkansas、アメリカ、72204
- Investigational Site Number 840015
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California
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Beverly Hills、California、アメリカ、90211
- Investigational Site Number 840086
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Loma Linda、California、アメリカ、92354
- Investigational Site Number 840018
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Merced、California、アメリカ、95348
- Investigational Site Number 840029
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Redwood City、California、アメリカ、94062
- Investigational Site Number 840044
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Santa Ana、California、アメリカ、92704
- Investigational Site Number 840042
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Vista、California、アメリカ、92083
- Investigational Site Number 840060
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Connecticut
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Stamford、Connecticut、アメリカ、06905
- Investigational Site Number 840057
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Delaware
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Newark、Delaware、アメリカ、19713
- Investigational Site Number 840002
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Wilmington、Delaware、アメリカ、19808
- Investigational Site Number 840063
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Florida
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Bradenton、Florida、アメリカ、34205
- Investigational Site Number 840070
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Jacksonville、Florida、アメリカ、32216
- Investigational Site Number 840010
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Jupiter、Florida、アメリカ、33458
- Investigational Site Number 840071
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Lakeland、Florida、アメリカ、33805
- Investigational Site Number 840061
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Lauderdale Lakes、Florida、アメリカ、33313
- Investigational Site Number 840096
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Ocala、Florida、アメリカ、34471
- Investigational Site Number 840031
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Orlando、Florida、アメリカ、32803
- Investigational Site Number 840074
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Ormond Beach、Florida、アメリカ、32174
- Investigational Site Number 840016
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St Petersburg、Florida、アメリカ、33709
- Investigational Site Number 840051
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Georgia
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Roswell、Georgia、アメリカ、30076
- Investigational Site Number 840081
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Illinois
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Jerseyville、Illinois、アメリカ、62052
- Investigational Site Number 840103
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Peoria、Illinois、アメリカ、61606
- Investigational Site Number 840106
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Indiana
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Elkhart、Indiana、アメリカ、46514
- Investigational Site Number 840066
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Kentucky
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Lexington、Kentucky、アメリカ、40504
- Investigational Site Number 840099
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Owensboro、Kentucky、アメリカ、42303
- Investigational Site Number 840039
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
- Investigational Site Number 840092
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Maine
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Auburn、Maine、アメリカ、04210
- Investigational Site Number 840040
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Massachusetts
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Ayer、Massachusetts、アメリカ、01432
- Investigational Site Number 840077
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Michigan
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Alpena、Michigan、アメリカ、49707
- Investigational Site Number 840050
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Saginaw、Michigan、アメリカ、48670
- Investigational Site Number 840041
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Minnesota
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Minneapolis、Minnesota、アメリカ、55422
- Investigational Site Number 840058
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Mississippi
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Picayune、Mississippi、アメリカ、39466
- Investigational Site Number 840101
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Missouri
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St Louis、Missouri、アメリカ、63122
- Investigational Site Number 840078
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St Louis、Missouri、アメリカ、63128
- Investigational Site Number 840038
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St. Louis、Missouri、アメリカ、63128
- Investigational Site Number 840102
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Montana
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Kalispell、Montana、アメリカ、59901
- Investigational Site Number 840012
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Nebraska
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Lincoln、Nebraska、アメリカ、68506
- Investigational Site Number 840090
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New York
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Bronx、New York、アメリカ、10468
- Investigational Site Number 840003
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Buffalo、New York、アメリカ、14215
- Investigational Site Number 840045
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Manhasset、New York、アメリカ、11030
- Investigational Site Number 840055
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Troy、New York、アメリカ、12180
- Investigational Site Number 840004
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Ohio
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Maumee、Ohio、アメリカ、43537
- Investigational Site Number 840009
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Pennsylvania
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Camp Hill、Pennsylvania、アメリカ、17011
- Investigational Site Number 840028
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Wyomissing、Pennsylvania、アメリカ、19610
- Investigational Site Number 840067
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Rhode Island
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Wakefield、Rhode Island、アメリカ、02879
- Investigational Site Number 840027
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Tennessee
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Knoxville、Tennessee、アメリカ、37917
- Investigational Site Number 840046
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Texas
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Longview、Texas、アメリカ、75605
- Investigational Site Number 840014
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Virginia
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Danville、Virginia、アメリカ、24541
- Investigational Site Number 840068
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Manassas、Virginia、アメリカ、20109
- Investigational Site Number 840069
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Richmond、Virginia、アメリカ、23249
- Investigational Site Number 840087
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Winchester、Virginia、アメリカ、22601
- Investigational Site Number 840085
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Washington
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Burien、Washington、アメリカ、98166
- Investigational Site Number 840013
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Spokane、Washington、アメリカ、99204
- Investigational Site Number 840091
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Wisconsin
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Madison、Wisconsin、アメリカ、53713
- Investigational Site Number 840080
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Milwaukee、Wisconsin、アメリカ、53215
- Investigational Site Number 840023
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Ontario
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Cambridge、Ontario、カナダ
- Investigational Site Number 124003
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Dronedarone
Dronedarone 400 mg twice a day
|
フィルムコーティング錠 摂食下での経口投与（朝食時および夕食時）
他の名前：
|
|
プラセボコンパレーター：Placebo
Placebo (for Dronedarone) twice a day
|
外観が厳密に同一のフィルムコーティング錠 摂食条件下（朝食時と夕食時）での経口投与 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline in Left Atrial Volume Index (LAVi)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes From Baseline in Left Atrial Function
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。