Heart FailureREFLECS-FINCT04444583
Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI
An observational study of Heart Failure and Heart Diseases, run by Precordior Ltd at 2 sites in Finland.
Trial summary
In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- How many people
- 155 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Jun 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting Turku University Hospital Heart Center or Heart and Lung Center at Helsinki University Hospital.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Heart and Lung Center at Helsinki University Hospital
Helsinki
Heart Center at Turku University Hospital
Turku
About this study
In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied.
Read the 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.
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFpEF | HF patients with preserved ejection fraction (HFpEF) | |
| HFrEF | HF patients with reduced ejection fraction (HFrEF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the hospital admission to study closure visit, on average 15 weeks
Secondary outcomes (1)
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).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precordior Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antti Saraste, MD, PhD, Principal investigator, Heart Center Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444583
- Sponsor's protocol ID
- REFLECS-FI
- Acronym
- REFLECS-FI
- Status last verified
- Jul 2025
- First submitted
- 17 Jun 2020
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI
- ClinicalTrials.gov ID
- NCT04444583
- Acronym / sponsor ID
- REFLECS-FI / REFLECS-FI
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Precordior LtdIndustry (pharma, biotech, devices)
- Collaborators
- Turku University Hospital, Helsinki University Central Hospital
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFpEF | – | –HF patients with preserved ejection fraction (HFpEF) |
| HFrEF | – | –HF patients with reduced ejection fraction (HFrEF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting Turku University Hospital Heart Center or Heart and Lung Center at Helsinki University Hospital.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Age <18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HF specific motion sensor characteristics validation against echocardiography and other clinical features
Time frame: 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.
1 secondary outcome
HF decompensation specific motion sensor characteristics validation
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antti Saraste, MD, PhD principal investigator
Heart Center Turku University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Diseases, run by Precordior Ltd at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HF specific motion sensor characteristics validation against echocardiography and other clinical features (time frame: From the hospital admission to study closure visit, on average 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.