REFLECS-FI: 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.
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.
Arms and Interventions
HF patients with preserved ejection fraction (HFpEF)
HF patients with reduced ejection fraction (HFrEF)
Primary Outcome Measures
- HF specific motion sensor characteristics validation against echocardiography and other clinical features [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 Outcome Measures
- HF decompensation specific motion sensor characteristics validation [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).
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
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.
Contacts and Locations
|1||Heart and Lung Center at Helsinki University Hospital||Helsinki||Finland|
|2||Heart Center at Turku University Hospital||Turku||Finland|
Sponsors and Collaborators
- Precordior Ltd
- Turku University Hospital
- Helsinki University Central Hospital
- Principal Investigator: Antti Saraste, MD, PhD, Heart Center Turku University Hospital
Study Documents (Full-Text)None provided.