跳至主要内容
临床试验/NCT02111538
NCT02111538已完成不适用

Prognostic Value of Phase Angle in Systemic Immunoglobulin Light-chain (AL) Amyloidosis

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
1
主要终点
Mortality

研究概览

简要总结

Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the prognosis predominantly depend on the presence and severity of cardiac involvement, it was shown that malnutrition is an independent predictor of survival and quality of life. However, the assessment of nutritional status by common indices based on anthropometry is not always feasible and accurate due to reduced performance status and/or the presence of fluid imbalances (for example edema and ascites). Several recent studies have demonstrated the prognostic value of the phase angle. Moreover, the value is supported by its applicability to patients who are bedridden or present alterations in the state of hydration.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Diagnosis of systemic immunoglobulin light-chain (AL) amyloidosis
  • Written informed consent

排除标准

  • Age <18 years
  • Ongoing artificial nutrition
  • Unavailability to planned measurements

结局指标

主要结局

Mortality

时间窗: 12 months

All-cause mortality at 12 months since baseline assessment

次要结局

  • Quality of life(6 months)
  • Mortality(12 months)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Riccardo Caccialanza

Physician

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

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