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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed consent
- •Age > 18 years
- •Subjects with a CF-LVAD or are scheduled to receive a CF-LVAD implant
排除标准
- •Psychiatric disorder or disease, irreversible cognitive dysfunction or psychosocial issues that might impair compliance with the study.
- •Patients already taking fish oil.
研究组 & 干预措施
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.
干预措施: Omega 3 fatty acids (Drug)
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.
干预措施: Placebo (Other)
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.
干预措施: Omega 3 fatty acids (Drug)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Change in Markers of Angiogenesis - Angiopoietin 1/2 and VEGF
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Changes in the Microbiome(The microbiome will be assessed at baseline at randomization, and at 3 months, 6 months, and 12 months after randomization.)
- Rates of Gastrointestinal Bleeding(Rates of bleeding will be measured at 3 months, 6 months, and 12 months after randomization.)