Trial Outcomes & Findings for Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging (NCT NCT00729430)

NCT ID: NCT00729430

Last Updated: 2017-06-01

Results Overview

Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 358 participants
• Primary outcome timeframe: Before and after study treatments
• Results posted on: 2017-06-01

Participant Flow

Participant milestones

Measure	High Dose Omega-3 Fatty Acid Arm Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
Overall Study STARTED	180	178
Overall Study COMPLETED	133	128
Overall Study NOT COMPLETED	47	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging

Baseline characteristics by cohort

Measure	High Dose Omega-3 Fatty Acid Arm n=180 Participants Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm n=178 Participants Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months	Total n=358 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 10 • n=93 Participants	58 years STANDARD_DEVIATION 10 • n=4 Participants	59 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	38 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	148 Participants n=93 Participants	140 Participants n=4 Participants	288 Participants n=27 Participants
Region of Enrollment United States	180 Participants n=93 Participants	178 Participants n=4 Participants	358 Participants n=27 Participants

PRIMARY outcome

Timeframe: Before and after study treatments

Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)

Outcome measures

Measure	High Dose Omega-3 Fatty Acid Arm n=180 Participants Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm n=178 Participants Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling	-5.4 Percent Change Standard Deviation 16.6	1.2 Percent Change Standard Deviation 20.9

SECONDARY outcome

Timeframe: Measured in the 3-year follow-up period after participant's last study visit

Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)

Outcome measures

Measure	High Dose Omega-3 Fatty Acid Arm n=180 Participants Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm n=178 Participants Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis	-2.1 Percent Change Standard Deviation 14	3.4 Percent Change Standard Deviation 15

SECONDARY outcome

Timeframe: Measured in the 3-year follow-up period after participant's last study visit

Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)

Outcome measures

Measure	High Dose Omega-3 Fatty Acid Arm n=180 Participants Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm n=178 Participants Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction	4.8 Percent Change Standard Deviation 11	2.1 Percent Change Standard Deviation 12

SECONDARY outcome

Timeframe: Measured in the 3-year follow-up period after participant's last study visit

Measured as change in infarct size from baseline to post-treatment (6-months)

Outcome measures

Measure	High Dose Omega-3 Fatty Acid Arm n=180 Participants Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm n=178 Participants Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
Effect of Omega-3 Fatty Acids on Infarct Size	-8.8 Percent Change Standard Deviation 39.9	-1.9 Percent Change Standard Deviation 57.7

Adverse Events

High Dose Omega-3 Fatty Acids Arm

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	High Dose Omega-3 Fatty Acids Arm n=180 participants at risk Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm n=178 participants at risk Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
Immune system disorders Allergic Reaction (Tongue Swelling)	0.56% 1/180 • Number of events 1 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.	0.00% 0/178 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.
Blood and lymphatic system disorders Bleeding	0.00% 0/180 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.	0.00% 0/178 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.

Other adverse events

Measure	High Dose Omega-3 Fatty Acids Arm n=180 participants at risk Participants will receive a highly purified form of omega-3 fatty acids for 6 months. Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months	Placebo Arm n=178 participants at risk Participants will receive placebo for 6 months. Placebo: Placebo tablets taken orally once per day for 6 months
Gastrointestinal disorders Fishy Taste in Mouth	4.4% 8/180 • Number of events 8 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.	1.1% 2/178 • Number of events 2 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.
Gastrointestinal disorders Nausea	5.6% 10/180 • Number of events 10 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.	5.1% 9/178 • Number of events 9 • Measured in the 3-year follow-up period after participant's last study visit Adverse events were evaluated every 2 months during the 6-month study drug period by an investigator with conducted scripted telephone interviews with each patient. Tolerance to study drug, adverse events, and pill counts were also evacuated during these interviews.

Additional Information

Dr. Raymond Y. Kwong, Director of Cardiac Magnetic Resonance Imaging

Brigham and Women's Hospital

Phone: 857-307-1960

Email: rykwong@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place