跳至主要内容
临床试验/NCT06634316
NCT06634316进行中(未招募)不适用

Nutritional Management of Sarcopenia in Patients With Heart Failure

Maimónides Biomedical Research Institute of Córdoba2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Muscle mass

研究概览

简要总结

Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients. There is a lack of evidence for supporting its use or the use of protein modules in other clinical conditions including patients with heart failure

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
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

入选标准

  • Patients with a previous admission due to HF in the previous 12 months
  • Moderate or severe LVEF
  • Both sexs
  • Age >18 years old.

排除标准

  • MDRD <15 ml/min
  • End-stage liver disease.

结局指标

主要结局

Muscle mass

时间窗: 6 months

Changes in muscle mass

Functionality

时间窗: 6 months

Changes in functionality determined by the up and go test

次要结局

  • Albumin(6 months)
  • C-RP(6 months)

研究者

发起方
Maimónides Biomedical Research Institute of Córdoba
申办方类型
Other
责任方
Sponsor

研究点 (2)

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