跳至主要内容
临床试验/NCT05753553
NCT05753553招募中不适用

Incidence and Echocardiographic Predictors of HFpEF in High-Risk Population Afferent to Italian Echo-labs Network

IRCCS Policlinico S. Donato6 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
6
主要终点
incidence of HFpEF

研究概览

简要总结

The evolving definitions of HF, the increasing attention of the medical community, and the aging of the population are some of the factors contributing to a still debated incidence and prevalence of HFpEF across the general and specific populations. Despite the current decline in new HF cases, HFpEF shows stable incidence according to epidemiological studies. Cardiovascular risk factors, such as a long history of hypertension, diabetes, obesity, and others seem to be associated with a higher HFpEFincidence. Nevertheless, the potential echocardiographic predictors of HFpEF have not been defined yet.

Hypothesis In a population at high risk for HFpEF, collected using a multicenter echo-lab network, the real incidence of HFpEF cases and echocardiographic predictors can be identified.

Aim 1: to define the incidence of HFpEF in a high-risk cohort of patients afferent to the Italian echo-lab network.

Aim 2: to explore the standard (2D and Doppler data) and advanced (LV and LA strain) echocardiographic parameters associated with and potential predictors of HFpEF.

Methods This is a multicenter, prospective, observational study involving an Italian echo labs network. According to inclusion and exclusion criteria, patients will be enrolled during standard echocardiographic evaluation. After signing informed consent, clinical and echocardiographic data will be collected. Thereafter, they will be followed up for major clinical events (cardiovascular death, HF requiring hospitalization, myocardial infarct, and atrial fibrillation) for a period of 12 months

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >65 years
  • Echocardiographic LV EF >50%
  • Diastolic dysfunction at echocardiography of at least grade 1
  • LV hypertrophy defined as: linear LV mass >115 in men, >95 g/m2 in women
  • Left atrium (LA) enlargement defined as LA volume > 34 mL/ m2

排除标准

  • Severe chronic renal failure (GFR <15)
  • Severe chronic obstructive pulmonary disease (COPD) (FEV1 <1)
  • More than moderate valve disease
  • Previous cardiac surgery
  • Previous LV EF <40%

结局指标

主要结局

incidence of HFpEF

时间窗: after 12 months from baseline

to define the incidence of HFpEF in a high-risk cohort of patients afferent to Italian echo-lab network

次要结局

  • predictors of HFpEF(after 12 months)

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Bandera

Principal Investigator

IRCCS Policlinico S. Donato

研究点 (6)

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