Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000609
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
1999-10-27
Brief Title:
Sudden Cardiac Death in Heart Failure Trial SCD-HeFT
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 years after being randomly assigned to amiodarone matched placebo or an implantable cardiac defibrillator ICD Median follow-up was 455 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
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 25 years after being randomly assigned to amiodarone matched placebo or an implantable cardiac defibrillator ICD Median follow-up was 455 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL055766 | NIH | None | httpsreporternihgovquickSearchU01HL055766 |