SCD-HeFT
Sudden Cardiac Death in Heart Failure

Protocol:

SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) is a placebo-controlled, randomized clinical trial sponsored by the National Heart Lung and Blood Institute of the National Institutes of Health (NIH) to study the use of implantable cardioverter-defibrillators (ICDs) in heart failure patients with poor heart pumping function (an ejection fraction 35 percent or less) who have not experienced a previous life-threatening irregular heartbeat.

Study:

• Objective: Determine if amiodarone and/or ICD therapy improve survival compared to placebo.
• Patients: 2,521 patients from 148 centers across the U.S., Canada and New Zealand were assigned to three treatment arms: ICD therapy, drug therapy (amiodarone) and a control arm (placebo). All patients suffered from either Class II or III heart failure (mild to moderate). Each group also received optimal conventional heart failure therapy (ACE-inhibitors, beta-blockers, etc.).
• Endpoint: All-cause reduction in mortality.
• Secondary endpoints: Cause-specific deaths (arrhythmic and non-arrhythmic), quality of life, cost-effectiveness and the effect of T-wave alternans testing.

Status:

• Start: First patient enrolled September16, 1997.
• Full enrollment: Enrollment ended July 19, 2001.
• Completion: The study closed on October 31, 2003. Preliminary results were announced at the American College of Cardiology (ACC) annual scientific sessions on March 8, 2004 in New Orleans.
• Publication: TBD

Results:

• In NYHA Class II or III, CHF patients with EF <35% on good background drug therapy, the mortality rate for placebo-controlled patients is 7.2% per year over 5 years.
• ICDs decrease mortality by 23%.
• Amiodarone, when used as a primary preventive agent, does not improve survival.

Significance:

• The SCD-HeFT results show that ICDs save the lives of people with moderate heart failure and poor heart pumping function, due to their risk of sudden cardiac arrest (SCA).
• Because SCA is responsible for 60 percent of deaths among Americans with heart failure, the findings from the trial also reinforce the importance of receiving ICD therapy as a preventative measure before experiencing an episode of SCA.
• Amiodarone, an oral medication previously believed to be the “gold-standard” anti-arrhythmic drug, was shown to be ineffective in preventing sudden cardiac death. This reinforces the fact that defibrillation is the only treatment that can stop a life-threatening heart rhythm once it occurs.
• SCD-HeFT is the largest and longest follow-up ICD trial ever conducted. Most previous heart failure ICD trials studied therapy among the most severe heart failure patients and had shorter follow-up periods. SCD-HeFT was designed to look at a broader class of heart failure patients and follow them longer with a control group more than twice the size of any previous heart failure trial.
• SCD-HeFT is the latest in a series of major medical studies demonstrating the life-saving benefits of ICDs. The results reinforce evidence from earlier trials e.g. MADIT, MUSTT, and MADIT II, which showed that ICDs significantly cut the risk of death (31 – 55 percent) in certain groups of heart attack survivors.

Sponsors:

• The National Heart Lung and Blood Institute of the National Institutes of Health (NIH) sponsored the study with funding from Medtronic, Inc. and Wyeth Pharmaceuticals.

Primary Investigators:

• Gust Bardy, MD, Seattle Institute for Cardiac Research/University of Washington
• Kerry Lee, PhD, Duke University College of Medicine
• Daniel Mark, MD, Duke University College of Medicine

For more information visit: www.scd-heft.com

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