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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
  Purpose

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


Condition Intervention Phase
Arrhythmia
Cardiovascular Diseases
Death, Sudden, Cardiac
Heart Diseases
Heart Failure, Congestive
Heart Failure
Drug: amiodarone
Device: defibrillators, implantable
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1997
Estimated Study Completion Date: April 2005
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

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients with New York Heart Association class II or class III heart failure and ejection fraction less than or equal to 35%.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000609

Sponsors and Collaborators
Investigators
Investigator: Kerry Lee Duke University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00000609     History of Changes
Other Study ID Numbers: 112
Study First Received: October 27, 1999
Last Updated: November 10, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Death
Death, Sudden
Death, Sudden, Cardiac
Heart Diseases
Heart Failure
Heart Arrest
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014