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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
35
Patients will receive 4 grams fish oil once daily
Standard of care
University of Chicago Medicine
Chicago, Illinois, United States
Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF
Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include Angiopoietin-1 (ng/mL), Angiopoietin-2 (ng/mL), and VEGF (ng/mL).
Time frame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Change in Markers of Angiogenesis - TNF-alpha
Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include TNF-alpha (pg/mL).
Time frame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Change in Markers of Inflammation - C-Reactive Protein
Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include c-reactive protein (mg/dL).
Time frame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Rates of Gastrointestinal Bleeding
Rates of Gastrointestinal Bleeding will be assessed.
Time frame: Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.
Changes in the Microbiome
The microbiome will be assessed using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.
Time frame: The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
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