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

NCT ID: NCT04444583

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Failure Heart Diseases Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HFpEF

HF patients with preserved ejection fraction (HFpEF)

No interventions assigned to this group

HFrEF

HF patients with reduced ejection fraction (HFrEF)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Precordior Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antti Saraste, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Turku University Hospital

Locations

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Heart and Lung Center at Helsinki University Hospital

Helsinki, , Finland

Site Status

Heart Center at Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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REFLECS-FI

Identifier Type: -

Identifier Source: org_study_id

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