Remote Monitoring of Cardiac Mechanics in Heart Failure Patients (SeismicHeart)

January 15, 2026 updated by: Samuel Schmidt, Aalborg University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Denmark
      • Aalborg, Denmark, Denmark, 9000
        • Recruiting
        • Aalborg University Hospital
        • Contact:
      • Herlev, Denmark, Denmark, 2730

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Other: Continuous monitroing
Continuous monitoring for 30 days with a small combined SCG and 1-lead ECG sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 60 days of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate and direction of Adjustement in Medical Therapy
Time Frame: During the 30 days
Adjustments in the use of loop diuretics (furosemide, metolazon, bumetanide and torasemide) will be noted during the study.
During the 30 days
Differences in Echocardiographic extracted strain pre and post study period
Time Frame: Day 1 and day 30
Strain (%) extracted from echocardiography at day 1 and day 30 at the study.
Day 1 and day 30
Score of Patient Experience
Time Frame: At day 30
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.
At day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University

Collaborators

Copenhagen University Hospital at Herlev
Aalborg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-20240038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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