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

Heart Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000609
• Other study ID #: 112
• Secondary ID: U01HL055766
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: May 12, 2016
• Start date: May 1997
• Est. completion date: April 2005

Study information

• Verified date: November 2005
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• Cardiovascular Diseases
• Death, Sudden
• Death, Sudden, Cardiac
• Heart Diseases
• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• amiodarone

Device:
• defibrillators, implantable

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (2)

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. Erratum in: N Engl J Med. 2005 May 19;352(20):2146. — View Citation

Kadish A. Prophylactic defibrillator implantation--toward an evidence-based approach. N Engl J Med. 2005 Jan 20;352(3):285-7. — View Citation