St. Jude Medical will sponsor the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) 10-year follow-up study, along with the National Heart, Lung, and Blood Institute.
The study will revisit 1,855 patients who participated in the original SCD-HeFT to determine long-term outcomes 10 years after their last recorded follow-up. Gust H. Bardy, MD, from the Seattle Institute for Cardiac Research, who was the principal investigator in the original trial, will lead the extended follow-up study as well.
According to the St. Paul, Minn.-based company, the goals of the follow-up study are:
- To compare 10-year mortality data of the remaining 1,855 SCD-HeFT patients in the three arms of the trial (ICD, placebo and amiodarone [Cordarone, Wyeth-Ayerst Laboratories]) since the close of the follow-up on Oct. 31, 2003.
- To obtain outcome data in the major subgroups of SCD-HeFT: ischemic versus non-ischemic; N.Y. Heart Association (NYHA) Class II HF versus NYHA Class III HF; and in women and minorities.
- To obtain 10-year ICD use rates, complication rates, lead failure rates and replacement rates.
- To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.
- To obtain 10-year hospitalization and major procedure data.
- To obtain 10-year quality of life data.