Trials / Terminated
TerminatedNCT00524862
Standard Drug Therapy vs. Implanted Defibrillator for Primary Prevention of Sudden Cardiac Death
Selective Strategy to Manage Arrhythmia Risk and Therapy With ICD
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5,000 (estimated)
- Sponsor
- Unity Health Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2011-04-01
- Completion
- 2011-04-01
- First posted
- 2007-09-05
- Last updated
- 2015-07-31
Locations
10 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00524862. Inclusion in this directory is not an endorsement.