Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004558
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-02-09
Brief Title:
Antiarrhythmic Effects of N-3 Fatty Acids
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:
2005-12
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 the antiarrhythmic effects of dietary N-3 fatty acids in patients with implanted defibrillators
Detailed Description:
BACKGROUND
Ventricular tachycardia VT and ventricular fibrillation VF are common causes of the 300000 sudden deaths occurring in the United States each year Most of these victims have associated heart disease most commonly coronary artery disease Populations consuming considerable quantities of fish and marine mammals have lower than expected mortality rates from coronary disease Interventional and observational trials have indicated that fatty fish consumption decreases the death rate from coronary artery disease in part by reducing the number of sudden deaths Animal and tissue culture studies both support the hypothesis that these beneficial effects are from the antiarrhythmic properties of n-3 long chained polyunsaturated fatty acids eicosapentaenoic and docosahexaenoic acids
DESIGN NARRATIVE
Prospective randomized double blinded trial Survivors of VT and VF with an implantable defibrillator were randomized 100 to dietary supplementation with n-3 polyunsaturated fatty acidsPUFA or 100 to a placebo Adherence to the supplement were assessed by measurements of plasma red cell and adipose tissue n-3 fatty acid concentrations The primary outcome variable was the incidence of recurrent VT or VF but secondary variables were also assessed using serial implantable cardioverter defibrillator ICD assessment correlation of the rhythms with the biochemical measurements of n-3 fatty acids hospitalization rates and quality of life The ICD was the best protection available to patients and stored rhythm electrograms which allowed documentation of rhythm endpoints
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Ventricular tachycardia VT and ventricular fibrillation VF are common causes of the 300000 sudden deaths occurring in the United States each year Most of these victims have associated heart disease most commonly coronary artery disease Populations consuming considerable quantities of fish and marine mammals have lower than expected mortality rates from coronary disease Interventional and observational trials have indicated that fatty fish consumption decreases the death rate from coronary artery disease in part by reducing the number of sudden deaths Animal and tissue culture studies both support the hypothesis that these beneficial effects are from the antiarrhythmic properties of n-3 long chained polyunsaturated fatty acids eicosapentaenoic and docosahexaenoic acids
DESIGN NARRATIVE
Prospective randomized double blinded trial Survivors of VT and VF with an implantable defibrillator were randomized 100 to dietary supplementation with n-3 polyunsaturated fatty acidsPUFA or 100 to a placebo Adherence to the supplement were assessed by measurements of plasma red cell and adipose tissue n-3 fatty acid concentrations The primary outcome variable was the incidence of recurrent VT or VF but secondary variables were also assessed using serial implantable cardioverter defibrillator ICD assessment correlation of the rhythms with the biochemical measurements of n-3 fatty acids hospitalization rates and quality of life The ICD was the best protection available to patients and stored rhythm electrograms which allowed documentation of rhythm endpoints
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 |
|---|---|---|---|
| R01HL061682 | NIH | None | httpsreporternihgovquickSearchR01HL061682 |