The purpose of this trial or study is to determine if cardiac resynchronization therapy (CRT) can be a benefit to people who have impaired heart function due to past treatment with chemotherapy and/or chest radiation. The investigators are looking to enroll approximately 30 eligible subjects with heart failure in this trial. All patients enrolled and registered in the study will be implanted with a cardiac resynchronization therapy device that includes an implantable cardiac defibrillator (CRT-D). Clinical histories, physical exams, and external device testing will be collected both at the time of enrollment in the trial and during follow-up study visits. Following implantation of the CRT-D, patients will be contacted by phone at 3 months and will have a scheduled clinic visit follow-up at 6 months.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
UCLA Cardiovascular Center
Los Angeles, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University
St Louis, Missouri, United States
New York Presbyterian Hospita/Columbia University Medical Center
New York, New York, United States
Univeristy of Rochester Medical Center
Rochester, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Change in Left Ventricular Ejection Fraction
The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months
Time frame: 6 months post implant
Number of Participants With All-Cause Mortality
Number of Participants with All-Cause Mortality in CRT-D patients
Time frame: 6 months post implant
Effects of CRT Therapy on Left Ventricular Volume at End Diastole
Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end diastole (LVEDV) between baseline and six months
Time frame: 6 months post implant
Effects of CRT Therapy on Left Ventricular Volume at End Systole
Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole (LVESV) between baseline and six months
Time frame: 6 months post implant
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