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

Completed

• Conditions: Cardiovascular Diseases; Heart Failure; Heart Diseases

• Registration Number: NCT04444583
• Lead Sponsor: Precordior Ltd

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-23
• Primary Completion: 2021-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (2)

Heart and Lung Center at Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Heart Center at Turku University Hospital; 🇫🇮 Turku, Finland