Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
Information source: National Heart, Lung, and Blood Institute (NHLBI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Heart Failure, Congestive; Heart Failure
Intervention: amiodarone (Drug); defibrillators, implantable (Device)
Phase: Phase 3
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s):
Kerry Lee, Affiliation: Duke University
Summary
To compare conventional treatment of congestive heart failure (CHF) with two experimental
interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).
Clinical Details
Study design: Treatment, Randomized
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. .
Eligibility
Minimum age: 19 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Patients with New York Heart Association class II or class III heart failure and ejection
fraction less than or equal to 35%.
Locations and Contacts
Additional Information
Related publications: Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH; Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005 Jan 20;352(3):225-37. Kadish A. Prophylactic defibrillator implantation--toward an evidence-based approach. N Engl J Med. 2005 Jan 20;352(3):285-7. No abstract available.
Starting date: May 1997
Ending date: April 2005
Last updated: November 10, 2005
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