Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Serum albumin levels
研究概览
简要总结
Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin
详细描述
Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin
Assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on:
- Inflammatory activity (C-reactive protein)
- The development of biomarkers (NTproBNP).
- The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (CRP ?2,5 mg / dl).
排除标准
- •Impending doom
- •Participating in other clinical trials
- •Treatment with ?-3 acids in the last month prior to admission
- •Percutaneous or surgical treatment of the cause of heart failure during hospitalization.
- •Pregnant women.
- •Renal failure on dialysis.
- •Chronic liver disease Child-Pugh B or C.
- •Acute infectious process.
- •Active malignant neoplasia.
研究组 & 干预措施
Intervention
4 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester.
干预措施: Polyunsaturated fatty acids omega-3 (Drug)
Control
Capsules of similar appearance and flavor without active drug
干预措施: Placebo (Drug)
结局指标
主要结局
Serum albumin levels
时间窗: Four weeks
Serum albumin levels in the fourth week
次要结局
- NTproBNP levels(Four weeks)
- Combined event of death from any cause or readmission for heart failure(Three months)
- C-reactive protein levels(Four weeks)
研究者
Juan Luis Bonilla Palomas
Head of Cardiology
Hospital San Juan de la Cruz