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

The University of Chicago

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Heart Failure; Gastrointestinal Bleeding

Treatments: Other: Placebo; Drug: Omega 3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT03784963

IRB18-0576

Details and patient eligibility

About

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.

Full description

A potential mechanism of bleeding in patients with continuous-flow left ventricular assist devices (CF-LVAD) is dysfunctional angiogenesis. Angiogenesis is a complicated process controlled by several markers. Previous studies have shown that elevated Angiopoietin-2 and TNF-alpha are associated with bleeding events in CF-LVAD patients.

Fish oil has anti-inflammatory and potentially anti-angiogenic properties. A retrospective study of CF-LVAD patients on high-dose fish oil showed a marked decrease in gastrointestinal bleeding rates in these patients. Additionally, these patients had lower levels of circulating Angiopoietin-2. Fish oil is known to have an effect on the microbiome, and the aforementioned effects may be seen in changes of the microbiota.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 4 patient groups, including a placebo group

Primary Prevention Intervention

Experimental group

Description:

In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.

Treatment:

Drug: Omega 3 fatty acids

Primary Prevention Non-Intervention

Placebo Comparator group

Description:

In patients with CF-LVAD who have not had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.

Treatment:

Other: Placebo

Secondary Prevention Intervention

Experimental group

Description:

In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to intervention will receive 4 grams of Nature Made Ultra Omega-3 Fish Oil once daily for 1 year along with standard of care.

Treatment:

Drug: Omega 3 fatty acids

Secondary Prevention Non-Intervention

Placebo Comparator group

Description:

In patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.

Treatment:

Other: Placebo