An Observational Study to Develop an Algorithm to Predict Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in multiple physiologic parameters from baseline that correlate with onset of dCHF
研究概览
简要总结
This is a prospective, observational pilot study designed to develop a mathematical algorithm capable of predicting decompensation of congestive heart failure (dCHF) using physiologic data collected from a non-invasive wearable device. Participants with a remote hemodynamic pulmonary artery pressure monitor will wear a wearable device continuously for up to 12 months. Wearable data will be analyzed in relation to the hemodynamic monitor defined sentinel events of heart failure decompensation to identify predictive signal patterns. Optional biospecimen (DNA, blood, urine) and voice sample collection will support future biomarker discovery.
详细描述
Participants with chronic congestive heart failure and using a pulmonary artery pressure monitor will be enrolled and followed for a minimum of 6 months and up to 12 months. Daily pulmonary artery (PA) pressures obtained via the remote monitoring device will serve as the reference standard for identifying decompensated CHF events ("sentinel events"), defined by sustained elevations in PA diastolic pressure associated with medication changes by the clinical care team.
Physiologic data from the wearable-including heart rate, heart rate variability, sleep metrics, activity levels, oxygen saturation and temperature-will be collected continuously and analyzed in the 1-7 days preceding and following sentinel events. Time-series statistical methods and machine-learning models will be used to develop a predictive algorithm for dCHF.
Participants may opt in to optional biospecimen collection (cheek swab DNA, plasma, urine) and weekly voice recordings to support future research into biomarkers and digital phenotypes associated with heart failure decompensation. The wearable data are not used for clinical decision-making, and all participants continue to receive standard heart failure care.
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
- •• Age ≥ 18 years
- •Current use of a hemodynamic sensoring device
- •At least 4 consecutive weeks of stabilized "goal" pulmonary artery pressures
- •Access to a personal smartphone with Wi-Fi or cellular connectivity
排除标准
- •• Inability to provide informed consent
- •Inability to read or understand English
- •Likely non-adherence to wearable device use
- •Prisoners
- •Pregnant females
研究组 & 干预措施
Patients with congestive heart failure
Patients will be monitored by a a tiny, battery-free pressure sensor implanted in a branch of the pulmonary artery via a right-heart catheterization, previously placed for a history of decompensating heart failure.
干预措施: wearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters (Device)
结局指标
主要结局
Changes in multiple physiologic parameters from baseline that correlate with onset of dCHF
时间窗: Up to 12 Months
Identification of reproducible changes in wearable physiologic data that occur in the 1-7 days preceding a hemodynamic monitoring device detection of elevated pulmonary artery pressure sustained over 2 days defined as a sentinel event of decompensated CHF.
次要结局
未报告次要终点