NCT03266029已完成不适用
Single-Arm Observational Double - Blind Study Designed to Clinically Evaluate Cordio Application in Adult Patients With ADHF
Cordio Medical1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2015年5月24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
- 89
- 试验地点
- 1
- 主要终点
- voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)
研究概览
简要总结
Observational study on ADHF patients at one site in Israel. After signing informed consent and undergoing screening assessments, eligible patients will record sentences into a smartphone. The app will upload the vocal data to the sponsor's servers for analysis. The patient will record at hospital: admittion, release. Before hospital release, if applicable and upon patient agrreement, an app will be installed in a smartphone in order to continue the recording at home.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ADHF (pulmonary congestion)
- •Known diagnosis of HF, with either preserved or reduced LVEF.
- •18+ years old.
- •Able to understand and provide written informed consent.
排除标准
- •Subjects unable to comply with the daily use of the application due to mental disorders.
- •GFR <25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis.
- •Subjects with congenital heart disease or mechanical right heart valve(s).
- •Airway and lung infection and Sepsis
- •Patients with severe alcohol or drug use.
- •Women who are pregnant or lactating.
结局指标
主要结局
voice recording analysis - system is being developed to distinguish between 'dry' and 'wet' clinical state in ADHF patients (Speech Measure- SM- parameter)
时间窗: 5 years
Anyalysis of voice recordings; admission vs. discharge
次要结局
未报告次要终点
研究者
研究点 (1)
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