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Machine Learning Enabled Time Series Analysis in Medicine

Pattern Recognition in Heart Rate Variability Using Fitness Trackers in Cardiovascular Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05802563
Acronym
ME-TIME
Enrollment
200
Registered
2023-04-06
Start date
2022-05-24
Completion date
2023-09-01
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Heart Failure, Systolic

Keywords

cardiovascular disease, Artificial intelligence, machine learning

Brief summary

The goal of this observational cohort study is to investigate the potential of fitness trackers in combination with machine learning algorithms to identify cardiovascular disease specific patterns. Two hundred participants will be enrolled: 1. 50 with heart failure 2. 50 with atrial fibrillation 3. 100 (healthy) individuals without the former two conditions All participants are given a Fitbit device and monitored for three months. Researchers will compare differences in heart rate variability patterns between the groups and devise a machine learning algorithm to detect these patterns automatically.

Interventions

Study subjects will wear a Fitbit fitness tracker

Sponsors

Delft University of Technology
CollaboratorOTHER
HagaZiekenhuis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* systolic heart failure (LVEF \< 35%) * Atrial fibrillation without heart failure * Individuals without cardiovascular disease

Exclusion criteria

* \> 85 years old * Recent pulmonary venous antrum isolation procedure (\<1 year) * (end stage) kidney failure * (end stage) liver failure * Study participants with known systemic active inflammatory disease * Study participants with impaired mental state * Inability to use a fitness tracker or mobile phone * Impaired cognition and inability to understand the study protocol

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular disease detection with an AI algorithmThree monthsadequate sensitivity/specificity in an algorithm to detect atrial fibrillation and heart failure

Secondary

MeasureTime frame
Detection of absence of cardiovascular diseaseThree months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026