N/A
N=30
Multicenter Automatic Defibrillator Implantation Trial - Chemotherapy-Induced Cardiomyopathy
Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT02164721 ↗Enrolled (actual)
30
Serious AEs
20.0%
Results posted
Mar 2020
Primary outcome: Primary: Change in Left Ventricular Ejection Fraction — 10.6 percentage of LVEF
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Three-lead CRT-D (Defibrillator) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular Ejection Fraction |
10.6 | — |
| SECONDARY Number of Participants With All-Cause Mortality |
— | — |
| SECONDARY Effects of CRT Therapy on Left Ventricular Volume at End Diastole |
-31.9 | — |
| SECONDARY Effects of CRT Therapy on Left Ventricular Volume at End Systole |
-37.0 | — |
Summary
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.
Eligibility Criteria
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, live
Data sourced from ClinicalTrials.gov (NCT02164721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.