跳至主要内容
临床试验/NCT06819618
NCT06819618招募中不适用

Predicting Heart Failure Recovery by Wearables and Machine Learning

University Medical Center Goettingen1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月1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
32
试验地点
1
主要终点
Re-hospitalization

研究概览

简要总结

In this monocentric observational study the research question is to what extent data collected via Apple Watch can predict the heart failure status of decompensated HF patients. For this purpose, physiological data from the Apple Watch (such as single-lead electrocardiogram, SpO2, respiratory rate, step count, nighttime temperature, etc.) will be extracted and used as predictor variables to forecast outcomes like risk of decompensation and rehospitalization within the follow-up period. Since this is a data-driven study, additional data collected as part of guideline-compliant treatment will also be included.

详细描述

Wearable devices for measuring vital functions, known as "wearables" from the consumer sector, such as the Apple Watch, have gained significant popularity. Increasingly, they are also being used for cardiovascular assessments. For example, a previous study at the Department of Cardiology and Pulmonology demonstrated that the Apple Watch is well-accepted by HF patients and that the average daily step count correlates significantly with the 6-minute walk test. Research has since shifted from simple correlation analyses to more complex tasks, such as predicting clinical laboratory measurements or events, like decompensation in HF patients.

Machine learning methods have proven to be suitable for various predictions in the field of heart failure. For instance, it has been shown that ECG data can be used to predict HF risk surrogates or comorbidities, such as NT-proBNP levels, age or gender, anemia, or renal insufficiency. Beyond ECG, multimodal approaches that combine multiple measurements have demonstrated the feasibility of data-driven HF risk assessment. Examples include combining cardiac MRI with clinical information to predict time to hospitalization or HF incidence rates in atrial fibrillation.

Since ECG alone does not provide sufficient prognostic value for heart failure (HF) assessment, this study aims to advance the state of the art by incorporating additional sensor data. The Apple Watch will be utilized as the device of choice. Extracted parameters include respiratory rate, oxygen saturation, nighttime temperature, acceleration data, and automatically provided derived parameters (e.g., step count, sleep times).

Specific Objectives:

  • Collect data from HF patients using the Apple Watch.
  • Extract and integrate the data into a unified format.
  • Perform correlation analysis with clinical parameters.
  • Develop an algorithm/model to predict clinical parameters.
  • Statistically evaluate the predictive power of the developed model.

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
否

入选标准

  • •age over 17
  • •HFrEF with LV-EF under 41
  • •hospitalized for decompensated heart failure with a) nTproBNP over 1000 AND b) willing to participate AND c) at least one out of three clinical signs (edema, pleural effusion, ascites)

排除标准

  • •life expectancy under 6 months due to non-cardiac conditions
  • •inability to use smartwatch
  • •severe valvular lesions

结局指标

主要结局

Re-hospitalization

时间窗: 3 Months after discharge from hospital

Re-hospitalization due to decompensated Heart Failure

次要结局

  • Adherence(From study enrollment until discharge (individual, usually from 5 to 15 days))
  • nTproBNP(At enrollment (t1), end of hospital stay = discharge (t2) and 3 months after discharge (t3))
  • Kansas City Cardiomyopathy-12 Score(At enrollment (t1), end of hospital stay = discharge (t2) and 3 months after discharge (t3))

研究者

发起方
University Medical Center Goettingen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soeren Sievers

Resident

University Medical Center Goettingen

研究点 (1)

Loading locations...

相似试验