Cardiovascular Atlas
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SCD-HeFT

A randomized trial in 2521 people with heart failure (New York Heart Association class II or III, ejection fraction 35% or less). All received usual heart failure care, plus placebo, the drug amiodarone, or an implantable cardioverter-defibrillator (ICD). After a median of 45.5 months, fewer people had died in the ICD group (22%) than in the placebo group (29%). The amiodarone group (28%) had a similar risk of death to the placebo group.

Also called Sudden Cardiac Death in Heart Failure Trial

  • Study
  • In this atlas

Overview

Design
Randomized, three-group trial. Conventional therapy plus placebo, conventional therapy plus amiodarone, or conventional therapy plus a conservatively programmed, shock-only, single-lead ICD; placebo and amiodarone were double-blind (abstract). The registry gives allocation randomized and primary purpose treatment.
Phase
Phase 3
Enrolled
  • 2,521 patients (randomized count) (Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT00000609
Started
(Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), retrieved )
Primary completion
Not reported
Completion
(actual) (Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), retrieved )
Countries
Not reported
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

ClinicalTrials.gov NCT00000609: a phase 3 randomized treatment study with the National Heart, Lung, and Blood Institute as lead sponsor, status completed, start 1997-05 (the registry gives no date type) and completion 2005-04 (actual). The record lists no locations, no enrollment count and no results; the 2521 randomized patients come from the abstract of the 2005 report (read only as a PubMed abstract). PubMed links an erratum published in May 2005 that was not read. The study's amiodarone and ICD results are on the claim; no structured findings are recorded here.

Arms

  • Conventional therapy plus placebo

    Intervention None named

    Conventional therapy for congestive heart failure plus placebo, 847 patients (abstract).

  • Conventional therapy plus amiodarone

    Intervention None named

    Conventional therapy for congestive heart failure plus amiodarone, 845 patients (abstract). No separate entity is recorded for amiodarone.

  • Conventional therapy plus ICD

    Intervention Implantable cardioverter-defibrillator (ICD)

    Conventional therapy for congestive heart failure plus a conservatively programmed, shock-only, single-lead ICD, 829 patients (abstract).

Findings

No findings are published for this study.

Record details

Record id
cardio:scd-heft
Content hash
cf9fb895f6b869234eb02d833e59e59437f981797825fe2f9b359a17a5416006