Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy

Completed · Not applicable

Conditions studied: Cardiomyopathy

In brief

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.

Key facts

Study ID: NCT02164721
Run by: University of Rochester
People needed: 30
Starts: 2014-11-01
Expected to finish: 2019-02-06
Last updated by the study team: 2020-03-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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