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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03784963
Recruitment Status : Terminated (Low enrollment)
First Posted : December 24, 2018
Results First Posted : July 13, 2021
Last Update Posted : July 13, 2021
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Gastrointestinal Bleeding Drug: Omega 3 fatty acids Other: Placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 23, 2019
Actual Primary Completion Date : July 15, 2020
Actual Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Primary Prevention Intervention
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
Patients will receive 4 grams fish oil once daily
Placebo Comparator: Primary Prevention Non-Intervention
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
Standard of care
Experimental: Secondary Prevention Intervention
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
Patients will receive 4 grams fish oil once daily
Placebo Comparator: Secondary Prevention Non-Intervention
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
Standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF [ Time Frame: 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).

  2. Change in Markers of Angiogenesis - TNF-alpha [ Time Frame: 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).

  3. Change in Markers of Inflammation - C-Reactive Protein [ Time Frame: 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 :
  1. Rates of Gastrointestinal Bleeding [ Time Frame: Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization. ]
    Rates of Gastrointestinal Bleeding will be assessed.

  2. Changes in the Microbiome [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784963


Locations
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United States, Illinois
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Ann Nguyen, MD University of Chicago
  Study Documents (Full-Text)

Documents provided by University of Chicago:
Study Protocol and Statistical Analysis Plan  [PDF] June 5, 2019

More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03784963    
Other Study ID Numbers: IRB18-0576
First Posted: December 24, 2018    Key Record Dates
Results First Posted: July 13, 2021
Last Update Posted: July 13, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Chicago:
Angiogenesis
Inflammation
Microbiome
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases