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

Congestive Heart Failure Clinical Trial

— SMART-ICD  

Official title:

Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00524862
• Other study ID #: 06368
• Status: Terminated
• Phase: N/A
• First received: August 29, 2007
• Last updated: July 30, 2015
• Start date: October 2007
• Est. completion date: April 2011

Study information

• Verified date: July 2015
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5000
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Output, Low
• Congestive Heart Failure
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Death, Sudden, Cardiac
• Heart Failure
• Low Cardiac Output
• Myocardial Ischemia
• Sudden Cardiac Death
• Ventricular Dysfunction

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences - Hamilton General	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	London Health Sciences - University Campus	London	Ontario
Canada	Trillium Health Centre - Mississauga	Mississauga	Ontario
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	Rouge Valley Health System - Centenary	Scarborough	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Institute for Clinical Evaluative Sciences, Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		minimum 1 year follow-up (maximum 6 year)	No
Secondary	1. Presumed arrhythmic (sudden death) mortality. 2. Major morbidity which includes mortality, hospitalization and major device complications		minimum 1 year; maximum 6 years	No