Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI
REFLECS-FI
1 other identifier
observational
155
1 country
2
Brief Summary
In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJuly 14, 2025
July 1, 2025
1.6 years
June 17, 2020
July 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
HF specific motion sensor characteristics validation against echocardiography and other clinical features
The study aims to validate HF specific characteristics obtained with accelerometer (m/s2) and gyroscope (degree/s) against the current gold standard, detailed echocardiography examination in individuals already diagnosed with HF. Data of anonymised subjects without diagnosed or suspected HF will be used as controls to study the detection of HF.
From the hospital admission to study closure visit, on average 15 weeks
Secondary Outcomes (1)
HF decompensation specific motion sensor characteristics validation
14 weeks
Study Arms (2)
HFpEF
HF patients with preserved ejection fraction (HFpEF)
HFrEF
HF patients with reduced ejection fraction (HFrEF)
Eligibility Criteria
Patients visiting Turku University Hospital Heart Center or Heart and Lung Center at Helsinki University Hospital.
You may qualify if:
- Age \>18 years
- Patients visiting hospital for heart failure, either outpatient clinic or cardiac ward
- Signed informed consent as an acceptance to participate to the trial
You may not qualify if:
- Age \<18 years
- Severe cardiac valve disease
- Previous prosthetic cardiac valve
- Major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment
- Patients with pacemaker
- Informed consent form not signed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Precordior Ltdlead
- Turku University Hospitalcollaborator
- Helsinki University Central Hospitalcollaborator
Study Sites (2)
Heart and Lung Center at Helsinki University Hospital
Helsinki, Finland
Heart Center at Turku University Hospital
Turku, Finland
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Antti Saraste, MD, PhD
Heart Center Turku University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 23, 2020
Study Start
June 1, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2024
Last Updated
July 14, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share