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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03784963
• Other study ID #: IRB18-0576
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 23, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: June 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Heart Failure
• Hemorrhage

Intervention

Drug:
• Omega 3 fatty acids
Patients will receive 4 grams fish oil once daily

Other:
• Placebo
Standard of care

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Primary	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).	Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Primary	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).	Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Secondary	Rates of Gastrointestinal Bleeding	Rates of Gastrointestinal Bleeding will be assessed.	Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.
Secondary	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.	The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.