Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy (MADIT-CHIC)
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|ClinicalTrials.gov Identifier: NCT02164721|
Recruitment Status : Completed
First Posted : June 17, 2014
Results First Posted : March 4, 2020
Last Update Posted : March 4, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Cardiomyopathy||Device: Three-lead CRT-D (Defibrillator)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||February 6, 2019|
|Actual Study Completion Date :||February 6, 2019|
Implantation of a three-lead CRT-D (Defibrillator) in all registered patients
Device: Three-lead CRT-D (Defibrillator)
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.
- Change in Left Ventricular Ejection Fraction [ Time Frame: 6 months post implant ]The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months
- Number of Participants With All-Cause Mortality [ Time Frame: 6 months post implant ]Number of Participants with All-Cause Mortality in CRT-D patients
- Effects of CRT Therapy on Left Ventricular Volume at End Diastole [ Time Frame: 6 months post implant ]Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end diastole (LVEDV) between baseline and six months
- Effects of CRT Therapy on Left Ventricular Volume at End Systole [ Time Frame: 6 months post implant ]Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole (LVESV) between baseline and six months
- Change in New York Heart Association (NYHA) Functional Class [ Time Frame: 6 months post implant ]Improvement in NYHA functional class between baseline and six months (yes/no), ie. change from NYHA class III to NYHA II.
- Change in Left Atrial Size [ Time Frame: 6 months post implant ]Change in left atrial size between baseline and six months
- Effects of CRT on Frequency of Heart Failure [ Time Frame: 6 months post implant ]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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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02164721
|United States, California|
|UCLA Cardiovascular Center|
|Los Angeles, California, United States, 90095|
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|University of South Florida|
|Tampa, Florida, United States, 33606|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|New York Presbyterian Hospita/Columbia University Medical Center|
|New York, New York, United States, 10032|
|Univeristy of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Valentina Kutyifa, MD, PhD||University of Rochester|
Documents provided by Valentina Kutyifa, University of Rochester:
|Responsible Party:||Valentina Kutyifa, Principal Investigator, University of Rochester|
|Other Study ID Numbers:||
|First Posted:||June 17, 2014 Key Record Dates|
|Results First Posted:||March 4, 2020|
|Last Update Posted:||March 4, 2020|
|Last Verified:||February 2020|
Cardiac resynchronization therapy