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

Heart Failure Clinical Trial

— REFLECS-FI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04444583
• Other study ID #: REFLECS-FI
• Status: Active, not recruiting
• Start date: June 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Precordior Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure

Locations

Country	Name	City	State
Finland	Heart and Lung Center at Helsinki University Hospital	Helsinki
Finland	Heart Center at Turku University Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Precordior Ltd	Helsinki University Central Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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