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

NCT03784963 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: IRB18-0576
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Gastrointestinal Bleeding

Keywords

Angiogenesis; Inflammation; Microbiome

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• Rates of Gastrointestinal Bleeding

  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 at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.

Study Arms (4)

Primary Prevention Intervention

EXPERIMENTAL

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.

Drug: Omega 3 fatty acids

Primary Prevention Non-Intervention

PLACEBO COMPARATOR

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.

Other: Placebo

Secondary Prevention Intervention

EXPERIMENTAL

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.

Drug: Omega 3 fatty acids

Secondary Prevention Non-Intervention

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Omega 3 fatty acids DRUG

Patients will receive 4 grams fish oil once daily

Primary Prevention Intervention; Secondary Prevention Intervention

Placebo OTHER

Standard of care

Primary Prevention Non-Intervention; Secondary Prevention Non-Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has signed consent
• Age \> 18 years
• Subjects with a CF-LVAD or are scheduled to receive a CF-LVAD implant

You may not qualify if:

• Psychiatric disorder or disease, irreversible cognitive dysfunction or psychosocial issues that might impair compliance with the study.
• Patients already taking fish oil.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Heart Failure; Gastrointestinal Hemorrhage; Inflammation

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Limitations and Caveats

Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.

Results Point of Contact

• Title: Dr. Ann Nguyen, MD
• Organization: The University of Chicago

anguyen3@medicine.bsd.uchicago.edu

773-702-9396

Study Officials

• Ann Nguyen, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 24, 2018
• Study Start: January 23, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)