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临床试验/NCT07375251
NCT07375251Enrolling By Invitation不适用

TELEMACO-S: a Telemonitoring Project in Cardiology and Technology Transfer Using Telemedicine

Valentina Micheluzzi1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
250
试验地点
1
主要终点
Reduction in the number of hospitalizations for acute heart failure decompensation

研究概览

简要总结

The primary objective of this research project is to prevent heart failure decompensation through a wearable-based telemonitoring system (smartwatches), with a focus on the development and validation of a multiparametric predictive score.

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

  • Age ≥ 18 years Diagnosis of stable heart failure Cognitively able to participate in the study No significant hearing impairment No significant visual impairment Sufficient ability to read and write in Italian Ownership of a smartphone with internet access

排除标准

  • Not fully compensated heart failure Lack of a smartphone with internet access

研究组 & 干预措施

Patients with heart failure

Patients with stable heart failure

结局指标

主要结局

Reduction in the number of hospitalizations for acute heart failure decompensation

时间窗: From the start of the study (14 July 2025) until the end of follow-up (31 March 2026), assessed up to approximately 8.5 months (up to 37 weeks)

Hospitalizations for acute heart failure decompensation assessed during the study period. Changes over time in the number of hospitalizations will be evaluated; a multiparametric score will be used to support clinical assessment.

次要结局

未报告次要终点

研究者

发起方
Valentina Micheluzzi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Valentina Micheluzzi

MSN, RN

Azienda Ospedaliero Universitaria di Sassari

研究点 (1)

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