Actively Recruiting
Predicting Heart Failure Recovery by Wearables and Machine Learning
Led by University Medical Center Goettingen · Updated on 2025-02-11
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how data collected from the Apple Watch can help predict the health status of patients with decompensated heart failure with reduced ejection fraction (HFrEF). This observational study focuses on using machine learning methods to analyze physiological data, such as single-lead electrocardiograms, oxygen levels, respiratory rate, step count, and nighttime temperature. The goal is to forecast risks like heart failure worsening and rehospitalization while also correlating wearable data with clinical parameters collected during guideline-compliant treatment. Participants will receive an Apple Watch to wear during their hospital stay, with data collected continuously. The watch will be given to patients upon admission and collected at discharge for offline analysis. Clinical data including blood tests, echocardiography, medication changes, and physical assessments will also be gathered at admission, discharge, and a follow-up visit 90 days after discharge. The study will use this combined data to develop and evaluate predictive models of heart failure outcomes. During the study, participants will be monitored through physiological data from the watch and clinical assessments including laboratory tests and echocardiography. The Kansas City Cardiomyopathy Questionnaire, NT-proBNP levels, and other blood markers will be measured at admission, discharge, and the 3-month follow-up. Researchers will assess rehospitalization rates and treatment adherence, using statistical methods to evaluate the accuracy of predictive models. The entire observation period spans from hospital admission through a 90-day post-discharge follow-up.
CONDITIONS
Brief Title
Prediction of Heart-Failure with Machine Learning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 17 years
- Diagnosis of heart failure with reduced ejection fraction (LV-EF under 41)
- Hospitalized for decompensated heart failure with nTproBNP over 1000
- Willingness to participate in the study
- Presence of at least one clinical sign: edema, pleural effusion, or ascites
You will not qualify if you...
- Life expectancy under 6 months due to non-cardiac conditions
- Inability to use a smartwatch
- Severe valvular heart valve lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for enrollment and introduction to the Apple Watch
Duration - Typically 5 to 15 days during hospitalization
Participants wear an Apple Watch to collect physiological data during their hospital stay while receiving guideline-compliant treatment for heart failure.
Data collected continuously during hospital stay; device given on admission and collected at discharge
Duration - 1 day (±10 days around 90 days post-discharge)
Participants return approximately 90 days after discharge for laboratory tests, echocardiography, and clinical assessment to evaluate heart failure status and rehospitalization.
1 follow-up visit (in-person) approximately 90 days after discharge
Trial Site Locations
Total: 1 location
1
University Medical Center Goettingen
Goettigen, Lower Saxony, Germany, 37075
Actively Recruiting
Research Team
S
Soeren Sievers, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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