Overview

This trial is active, not recruiting.

Conditions left ventricular systolic dysfunction, congestive heart failure, ischemic and non-ischemic cardiomyopathy, sudden cardiac death primary prevention
Sponsor Seattle Institute for Cardiac Research
Collaborator National Institutes of Health (NIH)
Start date September 2009
End date August 2011
Trial size 1855 participants
Trial identifier NCT01058837, 1RC1HL100625

Summary

No clinical trial that has examined the role of implantable cardioverter defibrillator (ICD) therapy in the prevention of Sudden Cardiac Death (SCD) has provided outcome data for longer than a few years. The NHLBI sponsored and placebo-controlled Sudden Cardiac Death in heart Failure Trial (SCD-HeFT) conducted from 1997 to 2003 had the largest number of patients and the longest average follow-up at 45.5 months. This study changed the national reimbursement policy for ICD therapy and remains the reference point for all other ICD evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. Despite the outcome, the role of ICD therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of therapy. The purpose of this trial is to track down the remaining patients for a one-time follow-up regarding key outcome data.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional

Primary Outcomes

Measure
To compare 10-year mortality data on the remaining 1855 SCD-HeFT patients since the close of follow-up from October 31, 2003 in the 3 arms of the trial (ICD, placebo and amiodarone)based upon an intent-to-treat and an on-treatment analysis.
time frame: Two years

Secondary Outcomes

Measure
To obtain outcome data in the major subgroups of SCD-HeFT: ischemic v. non-ischemic and NYHA Class II vs. Class III heart failure, and in woman and minorities.
time frame: Two years
To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates.
time frame: Two Years
To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients.
time frame: Two years
To obtain 10-year hospitalization and major procedure data.
time frame: Two years
To obtain 10-year quality of life data.
time frame: Two years

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: This is a one time follow-up on patients previously enrolled. - Exclusion Criteria: This is a one time follow-up on patients previously enrolled. -

Additional Information

Official title Sudden Cardiac Death in Heart Failure Trial 10 Year Follow-up (SCD-HeFT 10 Year)
Principal investigator Gust H. Bardy, MD
Description Long-term outcome data for implantable cardioverter defibrillator (ICD) therapy is sorely needed. We will acquire these data by re-approaching the patient population from the original Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).[Bardy 2005] This research is supported by the National Heart Lung and Blood Institute of the National Institutes of Health. SCD-HeFT was originally conducted from 1997 to 2003. It demonstrated unequivocally that ICD's save lives in patients with heart failure compared to placebo or amiodarone. More than 26 peer-reviewed publications, including three NEJM papers, have resulted from this work.[Bardy 2005, Poole 2008, Mark 2008] Despite the quality of SCD-HeFT and the evidence of the life-saving ability of ICD therapy, the role of ICD therapy in the management of patients with heart failure continues to be questioned. This study will provide long-term follow-up of the SCD-HeFT patients, which will now exceed 10 years on average.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Seattle Institute for Cardiac Research.