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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2005-002386-37 |
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The long-chain n-3 polyunsaturated fatty acids (PUFA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), appear to offer protection against sudden cardiac death and ventricular arrhythmias. EPA and DHA are essential fatty acids which are incorporated into cellular membranes after regular ingestion of fatty fish or fish oil.
This study investigates a possible acute effect of intravenous infusion of n-3 PUFA on inducibility of ventricular tachycardia (VT) in patients with an ICD-pacemaker.
The hypothesis is that an acute rise in the concentration of n-3 PUFA in plasma will increase the electric stability of the myocardial cells, so that VT is more difficult to induce.
In a randomized, placebo-controlled, double-blind, crossover study, a lipid emulsion with a high content of n-3 PUFA (or placebo: isotonic saline) will be administered intravenously before a non-invasive electrophysiologic examination performed via the ICD and following a predefined protocol.
The main outcome is inducibility of VT. If sustained VT is induced in a patient after both n-3 PUFA and placebo, the strength of the required stimulus after n-3 PUFA and after placebo is compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegaven | Drug | Lipid emulsion (omegaven) for intravenous use, 100 ml (25 mL/h) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inducibility of ventricular tachycardia | Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | Hours | |
| Ventricular repolarization parameters | Hours | |
| Concentration of n-3 fatty acids in plasma and platelet membranes |
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Inclusion Criteria:
Sustained ventricular tachycardia (VT) inducible during primary electrophysiological study (before ICD implantation) and one of the following
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trine Madsen, MD | Aalborg Hospital, Aarhus University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Aalborg Hospital | Aalborg | 9000 | Denmark |
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| Isotonic saline |
| Drug |
Intravenous infusion, 100 mL, 25mL/h |
|
| Hours |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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