NCT04644692已完成不适用
Positive Diagnosis of Heart Failure With Preserved LVEF by Exercise Pulmonary Ultrasound.
Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年1月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The exercise B-lines score measured by the 8-point method.
研究概览
简要总结
The E-LUS study is a prospective, non randomised, monocenter case-control study.
The main objective is to evaluate the association of exercise lung ultrasound data acquired during a stress test on a bicycle ergometer with the diagnosis of heart failure with preserved ejection fraction (HFpEF).
详细描述
Secondary objectives:
- To assess the diagnostic performance of exercise lung ultrasound for the diagnosis of HFpEF.
- To identify the value of the B-lines score on exercise maximizing the sensitivity and specificity for the diagnosis of HFpEF.
- To evaluate the relationship of the delta of B-lines scores between rest and exercise with the diagnosis of HFpEF.
- To assess the diagnostic performance of the delta of B-lines between rest and exercise for the diagnosis of HFpEF.
- To identify the score of the delta of B-lines value between rest and exercise maximizing sensitivity and specificity for the diagnosis of HFpEF.
- To evaluate the relationship between the resting value of the B-lines scores with the diagnosis of HFpEF.
- To assess the diagnostic performance of the resting lung ultrasound for the diagnosis of HFpEF.
- To identify the value of the B-lines score at rest maximizing the sensitivity and specificity for the diagnosis of HFpEF.
- To evaluate the correlation between the B-line score measured at rest and exercise and the dyspnoea score measured at rest, during exercise, and during the recovery phase.
- To assess the correlation of the delta of B-lines scores between rest and exercise and the dyspnoea score measured at rest, during exercise and during the recovery phase.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- 未提供
排除标准
- •Patients who are opposed to participate to the research project / the use of their data,
- •Pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images (e.g. pulmonary fibrosis, diffuse interstitial lung disease or lung cancer)
- •Patients with a history of thoracic surgery
- •Patients under legal protection measures (guardianship, curator, judicial safeguard),
- •Pregnant women, parturient women or nursing mothers,
- •Patients who are unable to express consent,
- •Persons deprived of their liberty by a judicial or administrative decision,
- •Persons subject to psychiatric care,
- •Patients discharged from hospital for a worsening heart failure hospitalization for less than 15 days
结局指标
主要结局
The exercise B-lines score measured by the 8-point method.
时间窗: Within 2 minutes after the end of the stress test
This score can have a value from 0 to 80, each anterior thoracic measurement point being rated from 0 to 10. A higher value indicate a higher level of pulmonary congestion. The measurement will be taken at the end of the stress test, in the first 2 minutes of recovery
次要结局
- 2. The delta of B-lines scores during exercise measured by the 8-point method between rest and the end of the exercise(Between Within 10 minutes prior the start of the stress test and 2 minutes after the end of the stress test)
- The diagnosis of HFpEF, as defined by a history of hospitalization for acute heart failure with preserved Left Ventricular Ejection Fraction (LVEF).(Within 10 minutes prior the start of the stress test)
- The B-lines score at rest measured by the 8-point method(Within 10 minutes prior the start of the stress test)
- The modified Borg dyspnea score at rest, during exercise and during recovery.(Within 10 minutes prior the start of the stress test, at the peak of exercise and 3 minutes after the end of the stress test)
研究者
Mathieu ECHIVARD
Praticien hospitalier
Central Hospital, Nancy, France
研究点 (1)
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