An observational study in Heart Failure and Heart Failure - NYHA II - IV, sponsored by Aalborg University. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Aalborg University · Observational
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.
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
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:
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aalborg University