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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Continuous monitroing
Other interventionContinuous monitoring for 30 days with a small combined SCG and 1-lead ECG sensor
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Differences in Echocardiographic extracted strain pre and post study period
Strain (%) extracted from echocardiography at day 1 and day 30 at the study.
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.
Sponsors and contacts
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Aalborg University
Lead sponsor
Aalborg University Hospital
Collaborator
Copenhagen University Hospital at Herlev
Collaborator