Clinical trial NCT03784963: Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD
Official title: Open-Label Prospective Randomized Control Trial to Investigate the Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With Continuous-Flow Left Ventricular Assist Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Gastrointestinal Bleeding
Keywords: Angiogenesis
Inflammation
Microbiome
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF
timeFrame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
measure: Change in Markers of Angiogenesis - TNF-alpha
timeFrame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
measure: Change in Markers of Inflammation - C-Reactive Protein
timeFrame: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Secondary outcomes:
measure: Rates of Gastrointestinal Bleeding
timeFrame: Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.
measure: Changes in the Microbiome
timeFrame: The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Ann Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: