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NCT Number: NCT06885164

Remote Monitoring of Cardiac Mechanics in Heart Failure Patients

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure - NYHA II - IV

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous monitroing

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel Schmidt, MSc, PhD

CONTACT

[email protected]

+4599407456

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Aalborg University Hospital
  • Copenhagen University Hospital at Herlev

Registry information

Official study title

Seismocardiographic Monitoring in Heart Failure

Acronym: SeismicHeart

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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