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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart and Lung Center at Helsinki University Hospital, Helsinki, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

HF specific motion sensor characteristics validation against echocardiography and other clinical features

Time frame: From the hospital admission to study closure visit, on average 15 weeks

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.

Secondary outcomes

HF decompensation specific motion sensor characteristics validation

Time frame: 14 weeks

The 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).

Sponsors and collaborators

Lead sponsor

Precordior Ltd

Industry

Collaborators

Helsinki University Central Hospital
Turku University Hospital

Registry information

Acronym: REFLECS-FI

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2024
First posted: Jun 23, 2020
Registry last updated: Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed