Congestive Heart Failure, Coronary Heart Disease, Low Cardiac Output, Sudden Cardiac Death, Ventricular Dysfunction
Conditions
Keywords
Implantable Cardioverter Defibrillator, Ejection Fraction, QRS duration
Brief summary
Recent ACC/AHA/ESC guidelines recommend prophylactic ICD implantation in most patients with coronary heart disease and LVEF \< 40%. Current Canadian guidelines recommend ICDs for primary prophylaxis in CAD patients with LVEF \< 30% (Class I recommendation). There are very sparse data to recommend ICD implantation in patients with EF between 30 and 40 %. This study will randomize patients with CHD and an EF between 30 and 40% to ICD therapy vs. No ICD therapy. The primary outcome is mortality and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD.
Interventions
Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
DEVICEImplantable Cardioverter Defibrillator
an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly
Sponsors
Institute for Clinical Evaluative Sciences
Ontario Ministry of Health and Long Term Care
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* documented chronic coronary heart disease (prior MI and/or angiographically documented CAD), \> 40 days post the most recent MI; * LVEF \< 40% (by MUGA) and NYHA functional class II or III at time of assessment OR LVEF ≤ 35 % (by MUGA) and NYHA functional class I, II or III at time of assessment * Judged to have a reasonable expectation of survival with a good functional status for more than 1 year, as well as receiving optimum, guideline recommended therapy for coronary artery disease and heart failure (or demonstrated intolerance or contraindications to such therapy). * Age ≥ 18 years; no upper age limitation.
Exclusion criteria
* Prior cardiac arrest, sustained VT or VF, or unexplained syncope. * Attempted VT / VF induction at electrophysiological study. * Need for a cardiac resynchronization therapy (CRT) device. * Enrollment in another interventional trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | minimum 1 year follow-up (maximum 6 year) |
Secondary
| Measure | Time frame |
|---|---|
| 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications | minimum 1 year; maximum 6 years |
Countries
Canada
Outcome results
None listed