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Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement (ODYSSEUS)

2013년 1월 10일 업데이트: Sanofi

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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

76

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • Investigational Site Number 840072
    • Arkansas
      • Little Rock, Arkansas, 미국, 72204
        • Investigational Site Number 840015
    • California
      • Beverly Hills, California, 미국, 90211
        • Investigational Site Number 840086
      • Loma Linda, California, 미국, 92354
        • Investigational Site Number 840018
      • Merced, California, 미국, 95348
        • Investigational Site Number 840029
      • Redwood City, California, 미국, 94062
        • Investigational Site Number 840044
      • Santa Ana, California, 미국, 92704
        • Investigational Site Number 840042
      • Vista, California, 미국, 92083
        • Investigational Site Number 840060
    • Connecticut
      • Stamford, Connecticut, 미국, 06905
        • Investigational Site Number 840057
    • Delaware
      • Newark, Delaware, 미국, 19713
        • Investigational Site Number 840002
      • Wilmington, Delaware, 미국, 19808
        • Investigational Site Number 840063
    • Florida
      • Bradenton, Florida, 미국, 34205
        • Investigational Site Number 840070
      • Jacksonville, Florida, 미국, 32216
        • Investigational Site Number 840010
      • Jupiter, Florida, 미국, 33458
        • Investigational Site Number 840071
      • Lakeland, Florida, 미국, 33805
        • Investigational Site Number 840061
      • Lauderdale Lakes, Florida, 미국, 33313
        • Investigational Site Number 840096
      • Ocala, Florida, 미국, 34471
        • Investigational Site Number 840031
      • Orlando, Florida, 미국, 32803
        • Investigational Site Number 840074
      • Ormond Beach, Florida, 미국, 32174
        • Investigational Site Number 840016
      • St Petersburg, Florida, 미국, 33709
        • Investigational Site Number 840051
    • Georgia
      • Roswell, Georgia, 미국, 30076
        • Investigational Site Number 840081
    • Illinois
      • Jerseyville, Illinois, 미국, 62052
        • Investigational Site Number 840103
      • Peoria, Illinois, 미국, 61606
        • Investigational Site Number 840106
    • Indiana
      • Elkhart, Indiana, 미국, 46514
        • Investigational Site Number 840066
    • Kentucky
      • Lexington, Kentucky, 미국, 40504
        • Investigational Site Number 840099
      • Owensboro, Kentucky, 미국, 42303
        • Investigational Site Number 840039
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70808
        • Investigational Site Number 840092
    • Maine
      • Auburn, Maine, 미국, 04210
        • Investigational Site Number 840040
    • Massachusetts
      • Ayer, Massachusetts, 미국, 01432
        • Investigational Site Number 840077
    • Michigan
      • Alpena, Michigan, 미국, 49707
        • Investigational Site Number 840050
      • Saginaw, Michigan, 미국, 48670
        • Investigational Site Number 840041
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55422
        • Investigational Site Number 840058
    • Mississippi
      • Picayune, Mississippi, 미국, 39466
        • Investigational Site Number 840101
    • Missouri
      • St Louis, Missouri, 미국, 63122
        • Investigational Site Number 840078
      • St Louis, Missouri, 미국, 63128
        • Investigational Site Number 840038
      • St. Louis, Missouri, 미국, 63128
        • Investigational Site Number 840102
    • Montana
      • Kalispell, Montana, 미국, 59901
        • Investigational Site Number 840012
    • Nebraska
      • Lincoln, Nebraska, 미국, 68506
        • Investigational Site Number 840090
    • New York
      • Bronx, New York, 미국, 10468
        • Investigational Site Number 840003
      • Buffalo, New York, 미국, 14215
        • Investigational Site Number 840045
      • Manhasset, New York, 미국, 11030
        • Investigational Site Number 840055
      • Troy, New York, 미국, 12180
        • Investigational Site Number 840004
    • Ohio
      • Maumee, Ohio, 미국, 43537
        • Investigational Site Number 840009
    • Pennsylvania
      • Camp Hill, Pennsylvania, 미국, 17011
        • Investigational Site Number 840028
      • Wyomissing, Pennsylvania, 미국, 19610
        • Investigational Site Number 840067
    • Rhode Island
      • Wakefield, Rhode Island, 미국, 02879
        • Investigational Site Number 840027
    • Tennessee
      • Knoxville, Tennessee, 미국, 37917
        • Investigational Site Number 840046
    • Texas
      • Longview, Texas, 미국, 75605
        • Investigational Site Number 840014
    • Virginia
      • Danville, Virginia, 미국, 24541
        • Investigational Site Number 840068
      • Manassas, Virginia, 미국, 20109
        • Investigational Site Number 840069
      • Richmond, Virginia, 미국, 23249
        • Investigational Site Number 840087
      • Winchester, Virginia, 미국, 22601
        • Investigational Site Number 840085
    • Washington
      • Burien, Washington, 미국, 98166
        • Investigational Site Number 840013
      • Spokane, Washington, 미국, 99204
        • Investigational Site Number 840091
    • Wisconsin
      • Madison, Wisconsin, 미국, 53713
        • Investigational Site Number 840080
      • Milwaukee, Wisconsin, 미국, 53215
        • Investigational Site Number 840023
  • 캐나다
    • Ontario
      • Cambridge, Ontario, 캐나다
        • Investigational Site Number 124003

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

21년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dronedarone
Dronedarone 400 mg twice a day
의약품: 드로네다론

필름코팅정

식사를 한 상태에서 경구 투여(아침 및 저녁 식사 중)

다른 이름들:
  • 물탁®
  • SR33589
위약 비교기: Placebo
Placebo (for Dronedarone) twice a day
의약품: 위약(Dronedarone용)

외관이 완전히 동일한 필름코팅정

식사를 한 상태에서 경구 투여(아침 및 저녁 식사 중)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Left Atrial Volume Index (LAVi)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Changes From Baseline in Left Atrial Function
기간: 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
기간: 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)
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sanofi

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 9월 1일

기본 완료 (실제)

2012년 1월 1일

연구 완료 (실제)

2012년 1월 1일

연구 등록 날짜

최초 제출

2010년 9월 9일

QC 기준을 충족하는 최초 제출

2010년 9월 9일

처음 게시됨 (추정)

2010년 9월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 2월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 1월 10일

마지막으로 확인됨

2013년 1월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DRONE_L_04315

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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