Heart FailurePhase 1/2NCT03784963

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

A Phase 1/2 study testing Omega 3 fatty acids in people with Heart Failure and Gastrointestinal Bleeding, run by University of Chicago at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Gastrointestinal Bleeding
What is being tested?: Omega 3 fatty acids
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 23 Jan 2019to 15 Jul 2020
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Chicago Medicine
Chicago, Illinois, 60637

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Heart Failure, Gastrointestinal Bleeding
Being tested: Omega 3 fatty acids, Placebo
Keywords: Angiogenesis, Inflammation, Microbiome
Medical subject headings: Heart Failure, Gastrointestinal Hemorrhage, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega 3 fatty acidsDrug
Patients will receive 4 grams fish oil once daily
PlaceboOther
Standard of care

Study groups in NCT03784963
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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 Gastrointestinal Bleeding will be assessed.
Measured: 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 using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.
Measured: The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jan 201915 Jul 2020

First posted24 Dec 2018
Study start23 Jan 2019
Primary completion15 Jul 2020
Study completion15 Jul 2020

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by University of ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03784963
Sponsor's protocol ID: IRB18-0576
Status last verified: Jun 2021
First submitted: 3 Dec 2018
Last updated: 13 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03784963
Acronym / sponsor ID: IRB18-0576
Conditions: Heart Failure, Gastrointestinal Bleeding
Keywords: Angiogenesis, Inflammation, Microbiome
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 35 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: 23 Jan 2019 (actual)
Primary completion: 15 Jul 2020 (actual)
Study completion: 15 Jul 2020 (actual)
First posted: 24 Dec 2018 (actual)
Results: Posted 13 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Primary Prevention Intervention	Experimental	Drug: Omega 3 fatty acidsIn 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.
Primary Prevention Non-Intervention	Placebo comparator	Other: PlaceboIn 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 Intervention	Experimental	Drug: Omega 3 fatty acidsIn 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.
Secondary Prevention Non-Intervention	Placebo comparator	Other: PlaceboIn patients with CF-LVAD who have had a gastrointestinal bleed, patients randomized to placebo will receive no fish oil and only standard of care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega 3 fatty acidsPatients will receive 4 grams fish oil once daily	Drug	Primary Prevention Intervention, Secondary Prevention Intervention
PlaceboStandard of care	Other	Primary Prevention Non-Intervention, Secondary Prevention Non-Intervention

Primary outcome

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).
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).
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).

2 secondary outcomes

Rates of Gastrointestinal Bleeding
Time frame: Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.
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.

Results and safety

Results posted to the registry on 13 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Prevention Intervention	12	0
Primary Prevention Non-Intervention	10	0
Secondary Prevention Intervention	1	0
Secondary Prevention Non-Intervention	0	0

Primary outcome: 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.

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

Primary outcome: 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.

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

Primary outcome: 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.

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected within the first year of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Prevention Intervention	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Primary Prevention Non-Intervention	1 of 10 (10%)	0 of 10 (0%)	0 of 10
Secondary Prevention Intervention	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Secondary Prevention Non-Intervention	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ann Nguyen, MD principal investigator

University of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Omega 3 fatty acids in people with Heart Failure and Gastrointestinal Bleeding, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03784963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.