Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Gastrointestinal Bleeding

In brief

This study evaluates the efficacy of high-dose fish oil in decreasing rates of gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices. Half of the patients without history of bleeding will receive fish oil while the other half will not. Half of the patients with history of bleeding will receive fish oil while the other half will not. Markers of angiogenesis and inflammation, as well as changes in the microbiome will be assessed in each group.

Key facts

Study ID

NCT03784963

Run by

University of Chicago

People needed

35

Starts

2019-01-23

Expected to finish

2020-07-15

Last updated by the study team

2021-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has signed consent
• Age > 18 years
• Subjects with a CF-LVAD or are scheduled to receive a CF-LVAD implant

You may not qualify if…

• Psychiatric disorder or disease, irreversible cognitive dysfunction or psychosocial issues that might impair compliance with the study.
• Patients already taking fish oil.

Where it is running

• University of Chicago Medicine — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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