Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004559
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-02-09
Brief Title:
Fatty Acid Antiarrhythmia Trial FAAT
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 determine if the dietary N-3 class of polyunsaturated fatty acids PUFAs provided in the diet largely from marine fish oils would prevent fatal ventricular tachycardia VT or ventricular fibrillation VF
Detailed Description:
BACKGROUND
Sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern Unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths This project would test whether a relatively inexpensive and presumably innocuous therapy fish oil supplements can prevent life-threatening arrhythmias There is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias and a clinical trial seems warranted
DESIGN NARRATIVE
Prospective randomized placebo-controlled double-blind Patients were randomized to 4 grams per day of a PUFA fish oil supplement versus an olive oil placebo The number of therapeutic discharges were recorded from the ICDs and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response The primary end point time to first ICD event for ventricular tachycardia or fibrillation VT or VF confirmed by stored electrograms or death from any cause was analyzed by intention to treat
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Sudden death is a common manifestation of ischemic heart disease and therefore of great public health concern Unfortunately several promising antiarrhythmic drugs proved not to be effective in preventing sudden deaths This project would test whether a relatively inexpensive and presumably innocuous therapy fish oil supplements can prevent life-threatening arrhythmias There is ample basic evidence that n-3 fatty acids contained in fish oil supplements may suppress arrhythmias and a clinical trial seems warranted
DESIGN NARRATIVE
Prospective randomized placebo-controlled double-blind Patients were randomized to 4 grams per day of a PUFA fish oil supplement versus an olive oil placebo The number of therapeutic discharges were recorded from the ICDs and then confirmed from the recorded electrocardiogram strips with the kinds of arrhythmias which had induced the ICD response The primary end point time to first ICD event for ventricular tachycardia or fibrillation VT or VF confirmed by stored electrograms or death from any cause was analyzed by intention to treat
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 |
|---|---|---|---|
| R01HL062154 | NIH | None | httpsreporternihgovquickSearchR01HL062154 |