Trial Outcomes & Findings for Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD (NCT NCT03784963)
NCT ID: NCT03784963
Last Updated: 2021-07-13
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.
Results posted on
2021-07-13
Participant Flow
Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
Participant milestones
| Measure |
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
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.
Placebo: Standard of care
|
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
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.
Placebo: Standard of care
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
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.
Placebo: Standard of care
|
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
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.
Placebo: Standard of care
|
|---|---|---|---|---|
|
Overall Study
Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.
|
12
|
10
|
1
|
0
|
Baseline Characteristics
Efficacy of Omega-3 Fatty Acid Therapy in Preventing Gastrointestinal Bleeding in Patients With CF-LVAD
Baseline characteristics by cohort
| Measure |
Primary Prevention Intervention
n=12 Participants
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
Primary Prevention Non-Intervention
n=10 Participants
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.
Placebo: Standard of care
|
Secondary Prevention Intervention
n=1 Participants
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
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.
Placebo: Standard of care
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
53.5 years
n=7 Participants
|
76 years
n=5 Participants
|
—
|
55 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ischemic
Ischemic
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ischemic
Non-Ischemic
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Dilated Cardiomyopathy
Dilated
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Dilated Cardiomyopathy
Not Dilated
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Diabetes Mellitus (DM)
Diabetes Mellitus
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Diabetes Mellitus (DM)
No Diabetes Mellitus
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Hypertension (HTN)
Hypertension
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Hypertension (HTN)
No Hypertension
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Cerebrovascular accident and Stroke (CVA)
Cerebrovascular accident and Stroke
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Cerebrovascular accident and Stroke (CVA)
No Cerebrovascular accident and Stroke
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Obstructive Sleep Apnea (OSA)
Obstructive Sleep Apnea
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Obstructive Sleep Apnea (OSA)
No Obstructive Sleep Apnea
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
No Chronic Obstructive Pulmonary Disease
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Pre-LVAD Implant New York Heart Association Class (NYHA)
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Pre-LVAD Implant New York Heart Association Class (NYHA)
2
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Pre-LVAD Implant New York Heart Association Class (NYHA)
3
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Pre-LVAD Implant New York Heart Association Class (NYHA)
4
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
1
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
2
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
3
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
5
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
6
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
LVAD Type
HeartMate II
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
LVAD Type
Heartware Ventricular Assisted Device (HVAD)
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
LVAD Type
Heart Mate III
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.Population: Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.Population: Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include TNF-alpha (pg/mL).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.Population: Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
Markers of angiogenesis and inflammation will be measured on customized Luminex assay panels. These will include c-reactive protein (mg/dL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.Population: Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.
Rates of Gastrointestinal Bleeding will be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.Population: Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
The microbiome will be assessed using rectal swabs. The swabs will be analyzed to determine the bacterial species present at each time point.
Outcome measures
Outcome data not reported
Adverse Events
Primary Prevention Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Prevention Non-Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Secondary Prevention Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Secondary Prevention Non-Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Primary Prevention Intervention
n=12 participants at risk
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
Primary Prevention Non-Intervention
n=10 participants at risk
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.
Placebo: Standard of care
|
Secondary Prevention Intervention
n=1 participants at risk
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.
Omega 3 fatty acids: Patients will receive 4 grams fish oil once daily
|
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.
Placebo: Standard of care
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea and indigestion
|
0.00%
0/12 • Adverse events were collected within the first year of the study.
Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects. Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected within the first year of the study.
Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects. Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.
|
0.00%
0/1 • Adverse events were collected within the first year of the study.
Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects. Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.
|
—
0/0 • Adverse events were collected within the first year of the study.
Patients were assessed at clinic for medication compliance and self-reported medication side effects, in addition to follow-up calls for any additional medication side effects. Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place