Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
Condition: Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Heart Failure, Congestive; Heart Failure
MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases; Death, Sudden, Cardiac; Death; Death, Sudden
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare conventional treatment of congestive heart failure (CHF) with two experimental
      interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).
    

Detailed description: 
      BACKGROUND:

      Congestive heart failure is a major cause of mortality and morbidity, and sudden arrhythmic
      death is the cause of death in from 30 to 50 percent of those who die. The study addresses
      the problem and tests two interventions that have promise of benefit. To date, many of the
      therapies that have been tested for congestive heart failure have either been ineffective or
      actually decreased survival. Conventional therapy is still relatively ineffective in that
      recent studies such as the Congestive Heart Failure - Survival Trial of Antiarrhythmic
      Therapy (CHF-STAT) have demonstrated a mortality of 40 percent during two-and-half years of
      follow-up. The implantable cardioverter-defibrillator appears to be effective in patients who
      are resuscitated from cardiac arrest, but until recently, the devices required a thoracotomy
      and had to be reserved for patients with the highest risk for sudden death. The newer
      transvenous devices with pectoral patches can now be considered for broader applications.
      Although there have been mixed results with amiodarone in patients with congestive heart
      failure, there is a general consensus that it could be effective in the proper subset of
      patients with congestive heart failure. A comparison of the optimal device and drug is
      appropriate for such a high risk population.

      DESIGN NARRATIVE:

      Three-armed, randomized, multicenter trial conducted at over 125 North American, Australian
      and New Zealand sites. Patients were enrolled over 2.5 years after being randomly assigned to
      amiodarone, matched placebo or an implantable cardiac defibrillator (ICD). Median follow-up
      was 45.5 months. All three arms used conventional therapy for heart failure and coronary
      artery disease (ACE inhibitors, lipid lowering and beta-blockers). The central hypothesis was
      that amiodarone or the ICD would improve survival compared to placebo. The primary outcome
      was the prevention of all-cause mortality. Secondary outcome measures included cardiac
      mortality and arrhythmic mortality, morbidity, quality of life, and incremental
      cost-effectiveness of the interventions.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): amiodarone; defibrillators, implantable
Intervention type(s): Drug; Device
Intervention MeSH terms: Amiodarone
Allocation: Randomized
Primary purpose: Treatment