Please select the eligibility criteria that correspond to the clinical trial below.
Title: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia, a Parallel, Placebo-Controlled, Double Blind Intervention Study
Brief Summary: The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).


Options:
A: Inclusion Criteria:

* Males or females with type 1 or type 2 diabetes mellitus.
* Aged ≥ 40 years.
* No previous history of vascular disease.
* No clear contra-indication to aspirin.
* No other predominant life-threatening medical problem.

Exclusion Criteria:

* Definite history of myocardial infarction, stroke or arterial revascularisation procedure.
* Currently prescribed aspirin, warfarin or any other blood thinning medication.
B: Inclusion Criteria:

* Men and women between the ages of 50 and 85 years
* Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye

Exclusion Criteria:

* Ocular media not clear enough to allow good fundus photography
C: Inclusion Criteria:

* Men and non-pregnant or sterile women ages 45 and older
* Hypertriglyceridemia
* On statin therapy for at least four weeks
* Either having established cardiovascular disease or at high risk for cardiovascular disease

Exclusion Criteria:

* Severe heart failure
* Any life-threatening disease other than cardiovascular disease
* Active severe liver disease
* Hemoglobin A1c \>10.0%
* Poorly controlled hypertension
* Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure
* Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)
* Known hypersensitivity to the study product, fish and/or shellfish, or placebo
* History of acute or chronic pancreatitis
* Patients are excluded if using the following medications:

  * PCSK9 inhibitors
  * niacin \>200 mg/day or fibrates;
  * any omega-3 fatty acid medications ;
  * dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
  * bile acid sequestrants
D: Inclusion Criteria:

* ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
* 18 years or older
* written informed consent

Exclusion Criteria:

* Primary prophylactic indication
* ICD implantation as a 'bridge' to heart transplantation
* Refractory supraventricular arrhythmias with rapid ventricular rates despite antiarrhythmic therapy
* a projected lifespan of less than 1 year
* participation in another trial (during or within 30 days before SOFA)
* use of any supplemental n-3 fatty acid during the last 3 months
* intake of more than 8g of n-3 fatty acids from fish per month as judged by a fish frequency questionnaire
* pregnant women and women of childbearing potential who do not use adequate contraception
* patients known to have a history of recent drug or alcohol abuse

Answer: D