Table 3.
Ongoing clinical trials investigating the application of digital devices and machine learning in HF cohorts.
| Clinical Trial | Wearable/Implantable | Description | Current Stage |
|---|---|---|---|
| Activity-Aware Prompting to Improve Medication Adherence in Heart Failure Patients (NCT04152031) [54] | Smartphone | Designing ML-based software algorithms aimed at analyzing daily behavior and to utilize it to improve medication compliance among patients with HF. | Recruitment complete |
| AIM-POWER study (NCT04191330) [53] | BiovitalsHF | To study the effectiveness of a cloud-based platform (BiovitalsHF) collecting data using remote wearable sensors in improving GDMT adoption among patients with HF. | Recruiting |
| ASE-INNOVATE study (NCT03713333) [59] | Multiple digital health devices | To study the effectiveness of technology-based visitations (outpatient visit supplemented by focused echocardiography, ECG, and vitals collected by digital devices) on long term cardiovascular outcomes. | Unclear |
| Heart Failure Monitoring With Eko Electronic Stethoscopes (CardioMEMS) (NCT05080504) [55] | Eko electronic stethoscopes (AI based) | Designing a ML-based algorithm which can correlate Eko stethoscope acoustic and ECG recordings with the pulmonary artery pressure measurements taken via the CardioMEMS device. | Recruiting |
| Interactive Patient’s Assistant-LUCY (NCT03474315) [56] | Implanted CRT and ICD devices | Designing a ML-based algorithm based on remotely monitored data to determine the parameters in CRT/ICD requiring an ambulatory device clinic visit, overall optimizing long term patient care. | Unclear |
| LINK-HF2 study (NCT04502563) [57] | Continuous remote monitoring via wearable sensors | To study the impact of remote monitoring on 90-day HF hospitalizations rate in patients with HF. | Recruiting |
| Validation of Ejection Fraction and Cardiac Output Using Biostrap Wristband (NCT05279066) [58] | Wristband with photoplethysmgraphy sensor | Correlation of ejection fraction and cardiac output measured via AI-powered translation of wristband PPG recordings with echocardiogram and pulmonary artery catheter measurements. | Recruiting |
| VESTA study (NCT04758429) [60] | Wearable sensor data | Validation of ML algorithm for early detection of HF events via multi-parametric sensor data. | Not yet recruiting |
Abbreviations: AI: Artificial Intelligence; ECG: Electrocardiogram; CRT: Cardiac resynchronization therapy; GDMT: Guideline directed medical therapy; HF: Heart Failure; ICD: Implantable cardiac defibrillator; PPG: Photoplethysmography.