aBOrdaje nutriCional en ADultos Seguidos en hOspitales eSpañoles Por Insuficiencia Cardiaca (BOCADOS-IC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- COMBINED EVENT
研究概览
简要总结
This is a randomized, controlled, open-label, prospective, multicentre clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic heart failure.
Through a simple 1:1 randomization process, patients will be assigned to the control group or the intervention group. Patients in the intervention group will undergo an individualised nutritional intervention program consisting of 3 pillars: diet optimization, specific recommendations ,and nutritional supplementation if nutritional targets are not achieved.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 65 years with malnutrition (MNA-SF score ≤ 11) with chronic ambulatory heart failure (HF).
排除标准
- •Admission for heart failure (HF) in the last month,
- •Chronic renal failure on dialysis.
- •Patients already on nutritional treatment.
- •Concomitant diseases which, apart from the HF itself, could lead to a life expectancy of less than 1 year,
- •Patients included in other clinical trials.
- •Patients whose clinical situation makes it impossible to perform a nutritional assessment according to the design established in the study protocol or who do not give their consent for this purpose.
- •Patients who during admission undergo surgical or percutaneous treatment to correct the cause of acute HF,
结局指标
主要结局
COMBINED EVENT
时间窗: 6 MONTHS
Time to the combined event of all-cause mortality or admission for heart failure at 6 months
次要结局
- Changes in nutritional status at 3 and 6 months post intervention(6 MONTHS)
- Time to all-cause admission at 6 months(6 MONTHS)
- Time to 6-month cardiovascular mortality(6 MONTHS)
- Changes in quality of life at 3 and 6 months post-intervention(6 MONTHS)
研究者
JOSE ANGEL PEREZ RIVERA
Principal Investigator
Spanish Society of Cardiology