Machine Learning Enabled Time Series Analysis in Medicine

NCT ID: NCT05802563

Last Updated: 2023-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-24

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Heart Failure, Systolic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Failure

Study participants with systolic heart failure (Left ventricular ejection fraction \< 35%) without documented atrial fibrillation

fitness tracker

Intervention Type DEVICE

Study subjects will wear a Fitbit fitness tracker

Atrial Fibrillation

Study participants with documented atrial fibrillation without heart failure

fitness tracker

Intervention Type DEVICE

Study subjects will wear a Fitbit fitness tracker

Reference

Individuals without cardiovascular disease

fitness tracker

Intervention Type DEVICE

Study subjects will wear a Fitbit fitness tracker

Interventions

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fitness tracker

Study subjects will wear a Fitbit fitness tracker

Intervention Type DEVICE

Other Intervention Names

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Fitbit Charge 5, Fitbit Inspire 2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Delft University of Technology

OTHER

Sponsor Role collaborator

HagaZiekenhuis

OTHER

Sponsor Role lead

Responsible Party

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Ivo van der Bilt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HagaZiekenhuis

The Hague, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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metime

Identifier Type: -

Identifier Source: org_study_id

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