Frailty Assessment in EldeRly Admitted to HoSpital to Receive Surgical or Percutaneous Procedure for Valvular Disorders Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- composite endpoint of all-cause mortality and all-cause hospital admission
研究概览
简要总结
In Italy, life expectancy at birth has reached 80 years in men and 85 in women; in about 50 years, life expectancy at the age of 80 has increased by an extraordinary 61% and 55%, respectively, due to more effective therapies and lower mortality of many diseases. Yet, chronic diseases are nowadays more important, and often coexist as comorbidity or multimorbidity, depending on whether an index condition has been considered. These conditions increase the risk of death and reduce functional autonomy in the elderly and, therefore, should be carefully considered within comprehensive geriatric assessment. The epidemiology of valvular disease shows a clear trend in age-dependent, as the number of events and their incidence increases with age, and about half are concentrates over 75 years.
In addition, some observational studies in elderly patients have suggested an association between frailty and cardiovascular disease: fragility and cardiovascular disease share a common biological pathway, and cardiovascular diseases may accelerate the onset of frailty. The frailty syndrome was identified in 25% to 50% of patients with cardiovascular disease, according to the rating scale used and the population studied. Frail patients with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease and aortic valve disease, have a much higher adverse events and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures.
Among the numerous tests proposed in the literature for the functional evaluation and objective measures of physical capability in elderly patient, the Short Physical Performance Battery (SPPB) and the evaluation of hand grip strength (grip strength) are those characterized by an improved prognostic ability and an easy administration.
The present study is performed to assess if SPPB and handgrip are helpful to better stratify the prognosis (all-causes death and hospital admission for all causes) in elderly patients admitted to hospital for cardiac causes.
详细描述
This is a prospective study. This a single centre study involving the Maria Cecilia Hospital (Ravenna, Italy).
The study is expected to enroll at least 450 consecutive patients with ≥70 years, which are admitted for:
GROUP A: severe aortic stenosis undergoing surgical aortic valve replacement GROUP B: severe aortic stenosis undergoing transcatheter valve implantation GROUP C: severe mitral regurgitation undergoing surgical repair GROUP D: severe mitral regurgitation undergoing MITRACLIP repair
In all patients, the following functional assessments will be performed before surgical/percutaneous intervention:
handgrip test (see definition below). Short Portable Mental Status Questionnaire (SPMSQ, see definition below). Short Physical Performance Battery (SPPB, see definition below). Multidimensional Prognostic Index (MPI, see definition below). The aim of the study is to assess the relationship between frailty score and prognosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospital admission for valvular disorders (severe aortic stenosis or severe mitral regurgitation) requiring surgical or percutaneous intervention
排除标准
- •SPMSQ value ≤4
- •inability to stay upright
- •life expectancy <3 months
结局指标
主要结局
composite endpoint of all-cause mortality and all-cause hospital admission
时间窗: 1-year
1-year cumulative incidence of all-cause mortality and all-cause hospital admission
次要结局
- cardiac death(1-year)
- all-cause mortality(1-year)
- cardiac adverse events(1-year)
研究者
Gianluca Campo
Associate Professor
University Hospital of Ferrara