Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death

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.

Conditions

• Coronary Heart Disease
• Congestive Heart Failure
• Ventricular Dysfunction
• Low Cardiac Output
• Sudden Cardiac Death

Interventions

DRUG

Optimized medical therapy

Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated

DEVICE

Implantable Cardioverter Defibrillator

an implanted device, called a defibrillator, which monitors heart rhythm and treats life-threatening rhythms accordingly

Sponsors & Collaborators

• Institute for Clinical Evaluative Sciences

  collaborator OTHER

• Ontario Ministry of Health and Long Term Care

  collaborator OTHER_GOV

• Unity Health Toronto

  lead OTHER

Principal Investigators

• Paul Dorian, MD · Unity Health Toronto

• Andreas Laupacis, MD · Li Ka Shing Knowledge Institute at St. Michael's Hospital

• Douglas Lee, MD · Institute for Clinical Evaluatuve Sciences

• Kevin Thorpe, MSc · Li Ka Shing Knowledge Institute at St. Michael's Hospital

• Marta Gadacz, MSc · Unity Health Toronto

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2011-04-30

Completion

2011-04-30

Countries

• Canada

Study Locations