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
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