Heart FailureSeismicHeartNCT06885164
Remote Monitoring of Cardiac Mechanics in Heart Failure Patients
An observational study of Heart Failure and Heart Failure - NYHA II - IV, run by Aalborg University at 2 sites in Denmark.
Trial summary
Heart failure is a severe heart disease, where the heart's ability to pump blood is unsatisfactory. The consequence is a high risk of hospitalization and death. Heart failure is treated with medicine which relieves symptoms and slows down the disease progression. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Failure, Heart Failure - NYHA II - IV
- What is being tested?
- Continuous monitroing
- How many people
- 200 participants
- Where
- 2 sitesDenmark
- Study dates
- 11 Jun 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants will be obtained from Aalborg University Hospital or Herlev-Gentofte Hospital in Denmark that are hospitalized or visits the heart failure clinic due to their heart failure.
Who may be able to join
- NYHA Class II or higher
- 18-90 years old
Who cannot join
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids, or other drugs
- Mechanical heart valves
- In dialysis
- Not possible to obtain clinical echocardiography of sufficient quality
- Lack of ability to coorperate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, Denmark, 9000
Peter Søgaard, MD, DMSc, +4597664439, p.soegaard@rn.dk
- Recruiting
Copenhagen University Hospital Herlev
Herlev, Denmark, 2730
Morten K Lamberts, MD, + 45 38 67 38 67, morten.kjoebek.lamberts@regionh.dk
About this study
Official title: Seismocardiographic Monitoring in Heart Failure
Heart failure is a severe heart disease, where the heart's ability to pump blood is unsatisfactory. The consequence is a high risk of hospitalization and death. Heart failure is treated with medicine which relieves symptoms and slows down the disease progression. This medical treatment needs routine adjustment, but in many cases, this adjustment is not done timely, which results in life treating conditions where the patients need acute hospitalization. Remote health monitoring of HF patients has the potential to ensure timely adjustment. However, only sensors placed inside the blood vessels of the lung, have been shown effective. The disadvantage is that the placement of the sensor requires surgery. This makes the method costly and poses a risk for the patient. The aim of the current project is to develop a small intelligent patch, which can measure the heart's function from the outside of the body. The method will be low-cost, simple to use and will not pose a risk to the patient.
Read the detailed description
The goal of this observational study is to gather data from heart failure participants, and to investigate whether it is possible to detect early alterations in heart failure based on this data. The main goals are
- Investigate whether parameters extracted from the measured data provide information regarding heart failure alterations
- Investigate if it is possible to detect alterations at early stages
The gathered data will be measured from a little sensor placed on sternum measuring acceleration (seismocardiography (SCG)) and electrocardiography (ECG) to provide an impression of the heart\'s mechanical function and electrical function, respectively. This data from the sensor will be analyzed with respect to other parameters obtained from, among others, echocardiography, total blood volume, changes in medical therapy, and hospitalization.
The included heart failure participants should be in the age group 18-90 years and in New York Heart Association Functional Classification (NYHA) class II or higher. Participants will wear the sensor to measure the participant\'s cardiac mechanics and electronics simultaneously. The participants will:
- wear the sensor for a period of 30 days from discharge or visit to heart failure clinic. The sensor will measure SCG and ECG for a short period (less than 30 seconds) once every hour,
- fill out questionnaires at first and last day of the study
- undergo echocardiography at first day and last day of the study
- not change everyday life because of the sensor
- Conditions
- Heart Failure, Heart Failure - NYHA II - IV
- Being tested
- Continuous monitroing
- Keywords
- heart failure, remote monitoring, cardiac mechanics
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous monitroingOther
Continuous monitoring for 30 days with a small combined SCG and 1-lead ECG sensor
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Participants | The included participants will be heart failure patients that are hospitalized or visits a heart failure clinic. The participants should be in NYHA Class II or higher and 18-90 years old. The participant should wear the sensor for 30 days, and it will measure every hour for the 30 days. Moreover, the participant should undergo echocardiography and answer questionnaire at enrollment day and at the last day of the study (day 30). Receives: Other: Continuous monitroing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Heart Failure Related Hospitalization
It will during the study be noted if an enrolled participant is hospitalized due to an alteration in heart failure condition.
Measured: Within 60 days of enrollment
Secondary outcomes (3)
Rate and direction of Adjustement in Medical Therapy
Adjustments in the use of loop diuretics (furosemide, metolazon, bumetanide and torasemide) will be noted during the study.
Measured: During the 30 days
Differences in Echocardiographic extracted strain pre and post study period
Strain (%) extracted from echocardiography at day 1 and day 30 at the study.
Measured: Day 1 and day 30
Score of Patient Experience
The participant's experiences using the sensor and compliance using the sensor. This will be obtained through a questionnaire fulfilled by enrolled participants. It is a System Usabaility Scale for use of the sensor. The score will be between 0 and 5. A higher score means better user experience with the system.
Measured: At day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start11 Jun 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Copenhagen University Hospital at Herlev
- Responsible party
- Principal investigator, Samuel Schmidt, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885164
- Sponsor's protocol ID
- N-20240038
- Acronym
- SeismicHeart
- Status last verified
- Jan 2026
- First submitted
- 10 Sep 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seismocardiographic Monitoring in Heart Failure
- ClinicalTrials.gov ID
- NCT06885164
- Acronym / sponsor ID
- SeismicHeart / N-20240038
- Conditions
- Heart Failure, Heart Failure - NYHA II - IV
- Keywords
- heart failure, remote monitoring, cardiac mechanics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Copenhagen University Hospital at Herlev
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Mar 2025 (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.
Heart failure is a severe heart disease, where the heart's ability to pump blood is unsatisfactory. The consequence is a high risk of hospitalization and death. Heart failure is treated with medicine which relieves symptoms and slows down the disease progression. This medical treatment needs routine adjustment, but in many cases, this adjustment is not done timely, which results in life treating conditions where the patients need acute hospitalization. Remote health monitoring of HF patients has the potential to ensure timely adjustment. However, only sensors placed inside the blood vessels of the lung, have been shown effective. The disadvantage is that the placement of the sensor requires surgery. This makes the method costly and poses a risk for the patient. The aim of the current project is to develop a small intelligent patch, which can measure the heart's function from the outside of the body. The method will be low-cost, simple to use and will not pose a risk to the patient.
Detailed description
The goal of this observational study is to gather data from heart failure participants, and to investigate whether it is possible to detect early alterations in heart failure based on this data. The main goals are
- Investigate whether parameters extracted from the measured data provide information regarding heart failure alterations
- Investigate if it is possible to detect alterations at early stages
The gathered data will be measured from a little sensor placed on sternum measuring acceleration (seismocardiography (SCG)) and electrocardiography (ECG) to provide an impression of the heart\'s mechanical function and electrical function, respectively. This data from the sensor will be analyzed with respect to other parameters obtained from, among others, echocardiography, total blood volume, changes in medical therapy, and hospitalization.
The included heart failure participants should be in the age group 18-90 years and in New York Heart Association Functional Classification (NYHA) class II or higher. Participants will wear the sensor to measure the participant\'s cardiac mechanics and electronics simultaneously. The participants will:
- wear the sensor for a period of 30 days from discharge or visit to heart failure clinic. The sensor will measure SCG and ECG for a short period (less than 30 seconds) once every hour,
- fill out questionnaires at first and last day of the study
- undergo echocardiography at first day and last day of the study
- not change everyday life because of the sensor
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Participants | – | Other: Continuous monitroingThe included participants will be heart failure patients that are hospitalized or visits a heart failure clinic. The participants should be in NYHA Class II or higher and 18-90 years old. The participant should wear the sensor for 30 days, and it will measure every hour for the 30 days. Moreover, the participant should undergo echocardiography and answer questionnaire at enrollment day and at the last day of the study (day 30). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be obtained from Aalborg University Hospital or Herlev-Gentofte Hospital in Denmark that are hospitalized or visits the heart failure clinic due to their heart failure.
Key inclusion criteria (2 listed)
- NYHA Class II or higher
- 18-90 years old
Key exclusion criteria (6 listed)
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids, or other drugs
- Mechanical heart valves
- In dialysis
- Not possible to obtain clinical echocardiography of sufficient quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous monitroingContinuous monitoring for 30 days with a small combined SCG and 1-lead ECG sensor | Other | Heart Failure Participants |
Primary outcome
Rate of Heart Failure Related Hospitalization
Time frame: Within 60 days of enrollment
It will during the study be noted if an enrolled participant is hospitalized due to an alteration in heart failure condition.
3 secondary outcomes
Rate and direction of Adjustement in Medical Therapy
Time frame: During the 30 days
Differences in Echocardiographic extracted strain pre and post study period
Time frame: Day 1 and day 30
Score of Patient Experience
Time frame: At day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- 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.
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 Failure - NYHA II - IV, run by Aalborg University at 2 sites in Denmark.
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 2 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: looking for participants now, as of the sponsor's last update on 16 Jan 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Schmidt, MSc, PhD (+4599407456, sschmidt@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Heart Failure Related Hospitalization (time frame: Within 60 days of enrollment). 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 16 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.