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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-23

Study Completion Date

2020-07-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure Gastrointestinal Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Primary Prevention Intervention

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.

Group Type EXPERIMENTAL

Omega 3 fatty acids

Intervention Type DRUG

Patients will receive 4 grams fish oil once daily

Primary Prevention Non-Intervention

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Standard of care

Secondary Prevention Intervention

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.

Group Type EXPERIMENTAL

Omega 3 fatty acids

Intervention Type DRUG

Patients will receive 4 grams fish oil once daily

Secondary Prevention Non-Intervention

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Standard of care

Interventions

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Omega 3 fatty acids

Patients will receive 4 grams fish oil once daily

Intervention Type DRUG

Placebo

Standard of care

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No