Remote Monitoring of Cardiac Mechanics in Heart Failure Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAalborg University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

NYHA Class II or higher

18-90 years old

Disqualifiers

Pregnancy

Drug addiction defined as the use of cannabis, opioids, or other drugs

Mechanical heart valves

In dialysis

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Continuous monitroing

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Heart Failure Participants1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 60 days of enrollment

Secondary outcomes

1

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.

Time frame
During the 30 days
2

Differences in Echocardiographic extracted strain pre and post study period

Strain (%) extracted from echocardiography at day 1 and day 30 at the study.

Time frame
Day 1 and day 30
3

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.

Time frame
At day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University

Lead sponsor

Aalborg University Hospital

Collaborator

Copenhagen University Hospital at Herlev

Collaborator