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Remote Monitoring of Cardiac Mechanics in Heart Failure Patients

Seismocardiographic Monitoring in Heart Failure

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06885164
Acronym
SeismicHeart
Enrollment
200
Registered
2025-03-20
Start date
2025-06-11
Completion date
2027-01-01
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Heart Failure - NYHA II - IV

Keywords

heart failure, remote monitoring, cardiac mechanics

Brief 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. 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

Interventions

OTHERContinuous monitroing

Continuous monitoring for 30 days with a small combined SCG and 1-lead ECG sensor

Sponsors

Aalborg University
Lead SponsorOTHER
Aalborg University Hospital
CollaboratorOTHER
Copenhagen University Hospital at Herlev
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* NYHA Class II or higher * 18-90 years old

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Heart Failure Related HospitalizationWithin 60 days of enrollmentIt will during the study be noted if an enrolled participant is hospitalized due to an alteration in heart failure condition.

Secondary

MeasureTime frameDescription
Rate and direction of Adjustement in Medical TherapyDuring the 30 daysAdjustments in the use of loop diuretics (furosemide, metolazon, bumetanide and torasemide) will be noted during the study.
Differences in Echocardiographic extracted strain pre and post study periodDay 1 and day 30Strain (%) extracted from echocardiography at day 1 and day 30 at the study.
Score of Patient ExperienceAt day 30The 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.

Countries

Denmark

Contacts

CONTACTSamuel Schmidt, MSc, PhD
sschmidt@hst.aau.dk+4599407456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026