The original SCD-HeFT study has proved the effectiveness of ICD therapy over placebo or Amiodarone (a medication used to treat irregular heartbeats) for a specific population of patients. It was instrumental in changing the national reimbursement policy for ICD therapy, said the company.
The SCD-HeFT findings remain a key reference point for all other ICD evaluations for patients with congestive heart failure (HF). The trial was conducted from 1997 to 2003, and studied 2,521 patients with HF for an average follow-up period of 45.5 months. It was, and remains the largest, longest and only placebo-controlled, randomised, multicenter trial of implantable cardioverter defibrillator (ICD) therapy.
The SCD-HeFT ten-year follow-up study is expected to attempt to investigate all surviving patients and those who have succumbed since the end of the original trial by recontacting the 148 institutions participating in the trial (136 in the US, 11 in Canada and one in New Zealand). The follow-up data obtained in this project will be merged with the original SCD-HeFT database collected during the original trial, thus providing a long-term follow-up profile on all patients that were enrolled.
The primary goals of the study are: to compare ten-year mortality data of the remaining 1,855 SCD-HeFT patients in the three arms of the trial (ICD, placebo and amiodarone), 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; New York Heart Association (NYHA) Class II HF versus NYHA Class III HF; and in women and minorities.
Mark Carlson, CMO and SVP of research and clinical affairs for the cardiac rhythm management division at St Jude Medical, said: “We believe the patient groups examined in SCD-HeFT can provide additional insights regarding the long-term benefits of ICD therapies.
“Our sponsorship of this study demonstrates our commitment to advancing the practice of medicine by providing physicians with clinically relevant information that has an impact the decisions they make about treating patients with heart failure.”