|
|
|
Study Facts
Study Design
Milestones
Study Facts
| Trial Design: |
Randomized, placebo-controlled trial
|
| Sponsor(s): |
National Heart Lung and Blood Institute
|
| Funding: |
Medtronic, Inc. Wyeth Pharmaceuticals
|
| Hypothesis: |
To determine, by intention to treat, if amiodarone (Cordarone: Wyeth pharmaceuticals) or conservatively programmed shock only ICD (Medtronic Model 7223) reduces all-cause mortality compared to placebo in patients with either ischemic or non-ischemic NYHA Class II or III CHF and ejection fraction <35%.
|
| Key Inclusion Criteria: |
- Class II or III CHF (ischemic or non-ischemic)
- LVEF <35%
- Not currently indicated for amiodarone, ICD, or pacemaker therapy
- > 18 years of age
|
| Primary Endpoint: |
All-cause mortality
|
Number of Patients:
|
2,521
|
| Average Length of Follow-Up: |
45.5 months
Vital status was known on all 2,521 patients at last follow up
|
| Number of Centers: |
148 in North America and New Zealand
|
|
|
|
