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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Heart Failure

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 Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients visiting Turku University Hospital Heart Center or Heart and Lung Center at Helsinki University Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HFpEF; HF patients with preserved ejection fraction (HFpEF)
HFrEF; HF patients with reduced ejection fraction (HFrEF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HF decompensation specific motion sensor characteristics validation	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).	14 weeks

Collaborators and Investigators

• Sponsor: Precordior Ltd
• Collaborators: Turku University Hospital; Helsinki University Central Hospital
• Investigators: Principal Investigator: Antti Saraste, MD, PhD, Heart Center Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 17, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Failure; Heart Diseases; Cardiovascular Diseases
• Other Study ID Numbers: REFLECS-FI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No