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Low enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 fatty acids | Drug | Patients will receive 4 grams fish oil once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Changes in the Microbiome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Nguyen, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
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Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data. | Posted | Markers will be measured at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea and indigestion | Gastrointestinal disorders | Systematic Assessment |
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Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Nguyen, MD | The University of Chicago | 773-702-9396 | anguyen3@medicine.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2019 | Apr 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006471 | Gastrointestinal Hemorrhage |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Other | Standard of care |
|
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. |
| 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ischemic | Count of Participants | Participants |
|
| Dilated Cardiomyopathy | Dilated cardiomyopathy is etiology of heart failure and a disease of the heart muscle of the left ventricle, specifically in its ability to dilate. | Count of Participants | Participants |
|
| Diabetes Mellitus (DM) | Count of Participants | Participants |
|
| Hypertension (HTN) | Count of Participants | Participants |
|
| Cerebrovascular accident and Stroke (CVA) | Count of Participants | Participants |
|
| Obstructive Sleep Apnea (OSA) | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disease (COPD) | Count of Participants | Participants |
|
| Pre-LVAD Implant New York Heart Association Class (NYHA) | NYHA class determines the functional status of the patient. There are classes I-IV. Class I is no symptoms and IV is symptoms at rest. | Count of Participants | Participants |
|
| Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) | The Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) identifies patients with advanced heart failure undergoing mechanical circulatory support (MCS) at risk of complications after MCS. The INTERMACS scale goes from 1-7, where INTERMACS 1 is "crash and burn" and 7 is stable at home with some symptoms. | Count of Participants | Participants |
|
| LVAD Type | Count of Participants | Participants |
|
| OG001 |
| 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 |
| OG002 | 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 |
| OG003 | 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 |
|
| 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). | Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data. | Posted | 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). | Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data. | Posted | 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. | Study terminated by PI for low/no enrollment. All efforts were taken to gather all possible data. | Posted | 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. | Study terminated by PI for low/no enrollment prior to primary and secondary endpoints. All efforts were taken to gather all possible data. | Posted | The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization. |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 | 0 | 10 | 1 | 10 | 0 | 10 |
| EG002 | 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 | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |