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

NCT00524862 | Terminated DMC

• 1 other identifier: 06368
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Keywords

Implantable Cardioverter Defibrillator; Ejection Fraction; QRS duration

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  minimum 1 year follow-up (maximum 6 year)

Secondary Outcomes (1)

• 1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications

  minimum 1 year; maximum 6 years

Study Arms (2)

1

OTHER

Drug: Optimized medical therapy

2

OTHER

Device: Implantable Cardioverter Defibrillator

Interventions

Optimized medical therapy DRUG

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

1

Implantable Cardioverter Defibrillator DEVICE

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

Also known as: ICD

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Institute for Clinical Evaluative Sciences: collaborator
• Ontario Ministry of Health and Long Term Care: collaborator

Study Sites (10)

Hamilton Health Sciences - Hamilton General

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences - University Campus

London, Ontario, N6A 5A5, Canada

Location

Trillium Health Centre - Mississauga

Mississauga, Ontario, L5B 1B8, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Rouge Valley Health System - Centenary

Scarborough Village, Ontario, M1E 5E9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Coronary Disease; Heart Failure; Ventricular Dysfunction; Cardiac Output, Low; Death, Sudden, Cardiac

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Pathologic Processes

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Paul Dorian, MD

  Unity Health Toronto

  STUDY CHAIR

• Andreas Laupacis, MD

  Li Ka Shing Knowledge Institute at St. Michael's Hospital

  STUDY DIRECTOR

• Douglas Lee, MD

  Institute for Clinical Evaluatuve Sciences

  STUDY DIRECTOR

• Kevin Thorpe, MSc

  Li Ka Shing Knowledge Institute at St. Michael's Hospital

  STUDY DIRECTOR

• Marta Gadacz, MSc

  Unity Health Toronto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: September 5, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

CA (10)