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

Sponsor
Precordior Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04444583
Collaborator
Turku University Hospital (Other), Helsinki University Central Hospital (Other)
180
Enrollment
2
Locations
37
Anticipated Duration (Months)
90
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or DiseaseIntervention/TreatmentPhase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    180 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI
    Actual Study Start Date :
    Jun 1, 2020
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    ArmIntervention/Treatment
    HFpEF

    HF patients with preserved ejection fraction (HFpEF)

    HFrEF

    HF patients with reduced ejection fraction (HFrEF)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Heart and Lung Center at Helsinki University HospitalHelsinkiFinland
    2Heart Center at Turku University HospitalTurkuFinland

    Sponsors and Collaborators

    • Precordior Ltd
    • Turku University Hospital
    • Helsinki University Central Hospital

    Investigators

    • Principal Investigator: Antti Saraste, MD, PhD, Heart Center Turku University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Precordior Ltd
    ClinicalTrials.gov Identifier:
    NCT04444583
    Other Study ID Numbers:
    • REFLECS-FI
    First Posted:
    Jun 23, 2020
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 7, 2021