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

Phase 1

Terminated

• Conditions: Heart Failure; Gastrointestinal Bleeding
• Interventions: Other: Placebo; Drug: Omega 3 fatty acids

• Registration Number: NCT03784963
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-24
• Study Start: 2019-01-23
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Results First Submitted: 2021-05-27
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Results First Posted: 2021-07-13
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Prevention Non-Intervention	Placebo	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.
Secondary Prevention Non-Intervention	Placebo	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.
Primary Prevention Intervention	Omega 3 fatty acids	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.
Secondary Prevention Intervention	Omega 3 fatty acids	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.

Primary Outcome Measures

Name	Time	Method
Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF	Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.	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).
Change in Markers of Angiogenesis - TNF-alpha	Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.	Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include TNF-alpha (pg/mL).
Change in Markers of Inflammation - C-Reactive Protein	Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.	Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include c-reactive protein (mg/dL).

Secondary Outcome Measures

Name	Time	Method
Rates of Gastrointestinal Bleeding	Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.	Rates of Gastrointestinal Bleeding will be assessed.
Changes in the Microbiome	The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.	The microbiome will be assessed using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.

Trial Locations

Locations (1)

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States