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Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI

Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04444583
Acronym
REFLECS-FI
Enrollment
155
Registered
2020-06-23
Start date
2020-06-01
Completion date
2024-12-31
Last updated
2025-07-14

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

Conditions

Cardiovascular Diseases, Heart Diseases, Heart Failure

Brief summary

In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied.

Detailed description

Heart Failure (HF) is a condition where heart is unable to maintain adequate volume of blood in circulation corresponding to prevailing physiological demand. Gyrocardiography is a technique that utilizes micro electromechanical sensors (MEMS), accelerometer and gyroscope, to detect vibrations and rotation of thorax caused by cardiac motion. The main purpose of this study is to test the ability of an app of a smartphone with embedded motion sensors, positioned on the chest which measures the movements and function of the heart, to identify patients with different types of heart failure and their characteristics, as compared with clinical diagnosis. Echocardiography will also be used to confirm changes in cardiac cardiac mechanics including strain, cardiac torsion, diastolic filling characteristics.

Interventions

None listed

Sponsors

Turku University Hospital
CollaboratorOTHER_GOV
Helsinki University Central Hospital
CollaboratorOTHER
Precordior Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
HF specific motion sensor characteristics validation against echocardiography and other clinical featuresFrom the hospital admission to study closure visit, on average 15 weeksThe 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.

Secondary

MeasureTime frameDescription
HF decompensation specific motion sensor characteristics validation14 weeksThe ability of the motion sensors to detect differences in myocardial mechanics in patients with decompensation episode compared to patients without decompensation episode, assessed by receiver operating characteristics (ROC).

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026