NCT00507390

Brief Summary

This is a hypothesis testing study, the hypothesis being that dietary supplements of n-PUFAs concentrates are anti-arrhythmic in ventricular arrhythmic substrates. Study Aims: To investigate whether dietary supplements of n-3 polyunsaturated fatty acid concentrates (2g PUFAs/day, Omacor) reduces MTWA (a surrogate endpoint for ventricular arrhythmia substrate) in patients with ICDs for malignant ventricular arrhythmias.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

July 25, 2007

Last Update Submit

October 24, 2016

Conditions

ArrhythmiaDefibrillators, Implantable

Keywords

fish oils

Outcome Measures

Primary Outcomes (1)

  • Change in microvolt T wave alternans status

    8 weeks

Study Arms (2)

A1

ACTIVE COMPARATOR

n-3 PUFAs

Dietary Supplement: n-3 polyunsaturated fatty acids (PUFAs)

A2

PLACEBO COMPARATOR

olive oil capsules

Dietary Supplement: olive oil

Interventions

n-3 polyunsaturated fatty acids (PUFAs)DIETARY_SUPPLEMENT

2g n-3 PUFAs once daily for 8 weeks

Also known as: Omacor
A1
olive oilDIETARY_SUPPLEMENT

1 capsule day

A2

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • implantable cardiovertor defibrillators
  • microvolt Twave alternans positive

You may not qualify if:

  • unstable angina
  • CHF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ninewells Hospital and medical School

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Fatty Acids, Omega-3OmacorOlive Oil

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Allan Struthers, MD

    University of Dundee

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Clinical Lecturer and Honorary Consultant Cardiologist

Study Record Dates

First Submitted

July 25, 2007

First Posted

July 26, 2007

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)