Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy (MADIT-CHIC)
調査の概要
詳細な説明
With the advent of new therapies and an increasing number of long-term cancer survivors, the incidence and consequently the interest in chemotherapy-induced cardiomyopathy (CHIC) have been increasing. CHIC is a dose-dependent cardiomyopathy and presents as congestive heart failure several months to years after the administration of chemotherapy and/or chest radiation that includes the heart.
Greater than one-half of the patients exposed to just this class of drugs will show evidence of cardiac dysfunction, with 5% presenting with overt symptomatic heart failure. The overall incidence of CHIC is significantly underestimated as within the US alone, greater than 60,000 patients receive just anthracyclines every year. Despite this, there is little data on their response to conventional heart failure therapy. There is some preliminary evidence from two small, retrospective case-series suggesting that patients with CHIC and evidence of conduction tissue disease (i.e. a wide electrocardiographic depolarization duration (QRS) may significantly benefit from cardiac resynchronization therapy (CRT).
MADIT-CHIC is a multicenter, non-randomized, prospective observational study. The primary aim is to determine if CRT-D (Defibrillator) in high-risk patients with chemotherapy-induced cardiomyopathy will significantly improve left ventricular ejection fraction (LVEF) by echocardiography within 6 months of initiating CRT without adversely affecting mortality.
The study will last 6 months and will be conducted in 10-15 clinical centers in the United States.
Following implantation of the CRT-D device (Defibrillator), patients will be followed for 6 months. The first follow-up contact will be by phone at which time study personnel will review the patient's health status. The last study contact will be a 6-month clinic visit. At the 6-month visit, the patient's health status will be reviewed, the functioning of the CRT-D (Defibrillator) will be tested and an echocardiogram will be conducted. After the 6-month visit, the study-required follow-up will have been completed and patients will continue to have CRT-D (Defibrillator) clinical follow-up based on their physicians direction.
During the course of the study, Subjects will as outlined in the inclusion criteria continue on stable optimal pharmacologic therapy for the cardiac condition that is guideline-based and may include one or more of the following medications: Loop diuretics, Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB), Aldosterone antagonists and/or Beta-blockers unless the subject is not indicated, contraindicated, or is intolerant of medication.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
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Los Angeles、California、アメリカ、90095
- UCLA Cardiovascular Center
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District of Columbia
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Washington、District of Columbia、アメリカ、20010
- MedStar Washington Hospital Center
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Florida
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Tampa、Florida、アメリカ、33606
- University of South Florida
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Missouri
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Saint Louis、Missouri、アメリカ、63110
- Washington University
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New York
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New York、New York、アメリカ、10032
- New York Presbyterian Hospita/Columbia University Medical Center
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Rochester、New York、アメリカ、14642
- Univeristy of Rochester Medical Center
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University Medical Center
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Texas
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Houston、Texas、アメリカ、77030
- MD Anderson Cancer Center
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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:
- Age 18 (or of legal age to give informed consent specific to state and national law) up to 80 years of age
- Male or Female
- Without clinical heart failure at initiation of chemotherapy/radiation-induced treatment for an underlying malignancy, but developed clinical heart failure (cardiomyopathy: reduced left ventricular ejection fraction (LVEF) with a left bundle branch block (LBBB)-type of conduction disturbance; see next inclusion item) 6 months or more after initiation of the chemotherapy without other evident cause of the cardiomyopathy.
Eligible for implantation of a CRT-D (cardiac resynchronization therapy-defibrillator) device according to one of the following options in currently available guidelines:
- Class 1: Left ventricular ejection fraction (LVEF) less than or equal to 35% AND sinus rhythm AND LBBB (left bundle branch block) with a QRS (electrocardiographic depolarization duration) duration greater than or equal to 150ms AND NYHA (New York Heart Association) class II, III or ambulatory IV symptoms on guideline-directed medical therapy
- Class 2a1: Left ventricular ejection fraction (LVEF) less than or equal to 35% AND sinus rhythm AND left bundle branch block (LBBB) with a QRS (electrocardiographic depolarization duration) duration 120-149ms AND New York Heart Classification (NYHA) class II, III or ambulatory IV symptoms on guideline-directed medical therapy
- Class 2a2: Left ventricular ejection fraction (LVEF) less than or equal to 35% AND sinus rhythm AND Non-left bundle branch block (LBBB) with a QRS(electrocardiographic depolarization duration) duration greater than or equal to 150ms AND New York Heart Classification (NYHA) class III or ambulatory IV symptoms on guideline-directed medical therapy
- On stable optimal pharmacologic therapy for the cardiac condition that is guideline-based and may include one or more of the following medications: Loop diuretics, Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB), Aldosterone antagonists and/or Beta-blockers unless the subject is not indicated, contraindicated, or is intolerant of medication.
Exclusion Criteria:
- Currently implanted pacemaker or implantable cardioverter defibrillator (ICD) device
- Previous implant with a CRT (cardiac resynchronization therapy)/CRT-D (cardiac resynchronization therapy-defibrillator) device
- Cardiac condition not presumed to be caused by chemotherapy
- Documented symptoms or hemodynamically unstable ventricular tachyarrhythmia
- On active chemotherapy (must be at least 6 calendar months after last chemotherapy)
- Permanent or chronic Atrial Fibrillation (AF), or cardioversion for AF within the past 3 calendar months before consent date
- Structural heart disease such as congenital heart disease, valvular heart disease, e.g., rheumatic valvular heart disease, amyloid heart disease, etc.
- Coronary artery bypass graft surgery or percutaneous coronary intervention within the past 3 calendar months before consent date
- Enzyme positive myocardial infarction within the past 3 calendar months prior to consent date
- Unstable angina requiring hospitalization, with diagnostic work up and intervention within the past 3 months prior to consent date
- Angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
- Class IV and expected to undergo transplant within study duration
- Current or past history of drug addiction or abuse that caused cardiomyopathy
- Pregnant or plans to become pregnant during the course of the trial.
- Recent cerebral vascular accident or transient ischemia attack within the previous 3 months prior to consent date
- Presence of any disease, other than the subject's cardiac or cancer disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., uremia, liver failure, active malignant disease, etc.
- Participating in any other clinical trial
- Unwilling or unable to cooperate with the protocol
- Lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
- Does not anticipate being a resident of the area for the scheduled duration of the trial
- Unwilling to sign the consent for participation
- Physician does not allow participation
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：CRT-D (Defibrillator)
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
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The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead.
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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 in Left Ventricular Ejection Fraction
時間枠：6 months post implant
|
The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months
|
6 months post implant
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With All-Cause Mortality
時間枠：6 months post implant
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Number of Participants with All-Cause Mortality in CRT-D patients
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6 months post implant
|
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Effects of CRT Therapy on Left Ventricular Volume at End Diastole
時間枠：6 months post implant
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Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end diastole (LVEDV) between baseline and six months
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6 months post implant
|
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Effects of CRT Therapy on Left Ventricular Volume at End Systole
時間枠：6 months post implant
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Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole (LVESV) between baseline and six months
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6 months post implant
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in New York Heart Association (NYHA) Functional Class
時間枠：6 months post implant
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Improvement in NYHA functional class between baseline and six months (yes/no), ie.
change from NYHA class III to NYHA II.
|
6 months post implant
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Change in Left Atrial Size
時間枠：6 months post implant
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Change in left atrial size between baseline and six months
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6 months post implant
|
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Effects of CRT on Frequency of Heart Failure
時間枠：6 months post implant
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Effects of CRT on the frequency of heart failure with end point of inpatient hospitalization with augmented treatment for heart failure
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6 months post implant
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Valentina Kutyifa, MD, PhD、University of Rochester
出版物と役立つリンク
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 (実際)
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。