Predicting Heart Failure Recovery by Wearables and Machine Learning
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
Soeren Sievers
Resident
University Medical Center Goettingen
