Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
Primary Purpose
Arrhythmia, Cardiovascular Diseases, Death, Sudden, Cardiac
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
amiodarone
defibrillators, implantable
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmia
Eligibility Criteria
Patients with New York Heart Association class II or class III heart failure and ejection fraction less than or equal to 35%.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000609
First Posted
October 27, 1999
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000609
Brief Title
Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To compare conventional treatment of congestive heart failure (CHF) with two experimental interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Diseases, Heart Failure, Congestive, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amiodarone
Intervention Type
Device
Intervention Name(s)
defibrillators, implantable
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with New York Heart Association class II or class III heart failure and ejection fraction less than or equal to 35%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Lee
Organizational Affiliation
Duke University
12. IPD Sharing Statement
Citations:
PubMed Identifier
15659722
Citation
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. doi: 10.1056/NEJMoa043399. Erratum In: N Engl J Med. 2005 May 19;352(20):2146.
Results Reference
background
PubMed Identifier
15659729
Citation
Kadish A. Prophylactic defibrillator implantation--toward an evidence-based approach. N Engl J Med. 2005 Jan 20;352(3):285-7. doi: 10.1056/NEJMe048351. No abstract available.
Results Reference
background
PubMed Identifier
31412732
Citation
Reeder HT, Shen C, Buxton AE, Haneuse SJ, Kramer DB. Joint Shock/Death Risk Prediction Model for Patients Considering Implantable Cardioverter-Defibrillators. Circ Cardiovasc Qual Outcomes. 2019 Aug;12(8):e005675. doi: 10.1161/CIRCOUTCOMES.119.005675. Epub 2019 Aug 15.
Results Reference
derived
PubMed Identifier
27514751
Citation
Upshaw JN, Konstam MA, Klaveren Dv, Noubary F, Huggins GS, Kent DM. Multistate Model to Predict Heart Failure Hospitalizations and All-Cause Mortality in Outpatients With Heart Failure With Reduced Ejection Fraction: Model Derivation and External Validation. Circ Heart Fail. 2016 Aug;9(8):e003146. doi: 10.1161/CIRCHEARTFAILURE.116.003146.
Results Reference
derived
PubMed Identifier
24727258
Citation
Fishbein DP, Hellkamp AS, Mark DB, Walsh MN, Poole JE, Anderson J, Johnson G, Lee KL, Bardy GH; SCD-HeFT Investigators. Use of the 6-min walk distance to identify variations in treatment benefits from implantable cardioverter-defibrillator and amiodarone: results from the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2014 Jun 17;63(23):2560-2568. doi: 10.1016/j.jacc.2014.02.602. Epub 2014 Apr 9.
Results Reference
derived
PubMed Identifier
23541974
Citation
Chen J, Johnson G, Hellkamp AS, Anderson J, Mark DB, Lee KL, Bardy GH, Poole JE. Rapid-rate nonsustained ventricular tachycardia found on implantable cardioverter-defibrillator interrogation: relationship to outcomes in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol. 2013 May 28;61(21):2161-8. doi: 10.1016/j.jacc.2013.02.046. Epub 2013 Mar 26.
Results Reference
derived
PubMed Identifier
23280225
Citation
Al-Khatib SM, Hellkamp A, Bardy GH, Hammill S, Hall WJ, Mark DB, Anstrom KJ, Curtis J, Al-Khalidi H, Curtis LH, Heidenreich P, Peterson ED, Sanders G, Clapp-Channing N, Lee KL, Moss AJ. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA. 2013 Jan 2;309(1):55-62. doi: 10.1001/jama.2012.157182.
Results Reference
derived
PubMed Identifier
20884379
Citation
Strauss DG, Poole JE, Wagner GS, Selvester RH, Miller JM, Anderson J, Johnson G, McNulty SE, Mark DB, Lee KL, Bardy GH, Wu KC. An ECG index of myocardial scar enhances prediction of defibrillator shocks: an analysis of the Sudden Cardiac Death in Heart Failure Trial. Heart Rhythm. 2011 Jan;8(1):38-45. doi: 10.1016/j.hrthm.2010.09.071. Epub 2010 Sep 25.
Results Reference
derived
PubMed Identifier
19917887
Citation
Packer DL, Prutkin JM, Hellkamp AS, Mitchell LB, Bernstein RC, Wood F, Boehmer JP, Carlson MD, Frantz RP, McNulty SE, Rogers JG, Anderson J, Johnson GW, Walsh MN, Poole JE, Mark DB, Lee KL, Bardy GH. Impact of implantable cardioverter-defibrillator, amiodarone, and placebo on the mode of death in stable patients with heart failure: analysis from the sudden cardiac death in heart failure trial. Circulation. 2009 Dec 1;120(22):2170-6. doi: 10.1161/CIRCULATIONAHA.109.853689. Epub 2009 Nov 16. Erratum In: Circulation. 2010 Feb 16;121(6):e39.
Results Reference
derived
PubMed Identifier
19704100
Citation
Levy WC, Lee KL, Hellkamp AS, Poole JE, Mozaffarian D, Linker DT, Maggioni AP, Anand I, Poole-Wilson PA, Fishbein DP, Johnson G, Anderson J, Mark DB, Bardy GH. Maximizing survival benefit with primary prevention implantable cardioverter-defibrillator therapy in a heart failure population. Circulation. 2009 Sep 8;120(10):835-42. doi: 10.1161/CIRCULATIONAHA.108.816884. Epub 2009 Aug 24.
Results Reference
derived
PubMed Identifier
18371559
Citation
Olshansky B, Poole JE, Johnson G, Anderson J, Hellkamp AS, Packer D, Mark DB, Lee KL, Bardy GH; SCD-HeFT Investigators. Syncope predicts the outcome of cardiomyopathy patients: analysis of the SCD-HeFT study. J Am Coll Cardiol. 2008 Apr 1;51(13):1277-82. doi: 10.1016/j.jacc.2007.11.065.
Results Reference
derived
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Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)
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