Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000609
First received: October 27, 1999
Last updated: November 10, 2005
Last verified: November 2005

October 27, 1999
November 10, 2005
May 1997
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Complete list of historical versions of study NCT00000609 on ClinicalTrials.gov Archive Site
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Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
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To compare conventional treatment of congestive heart failure (CHF) with two experimental interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).

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. .

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
  • Arrhythmia
  • Cardiovascular Diseases
  • Death, Sudden, Cardiac
  • Heart Diseases
  • Heart Failure, Congestive
  • Heart Failure
  • Drug: amiodarone
  • Device: defibrillators, implantable
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2005
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Patients with New York Heart Association class II or class III heart failure and ejection fraction less than or equal to 35%.

Both
19 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000609
112
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Kerry Lee Duke University
National Heart, Lung, and Blood Institute (NHLBI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP