Remote Monitoring of Cardiac Mechanics in Heart Failure Patients

NCT06885164 | Recruiting DMC

• 1 other identifier: N-20240038
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure; Heart Failure - NYHA II - IV

Keywords

heart failure; remote monitoring; cardiac mechanics

Outcome Measures

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.

  Within 60 days of enrollment

Secondary Outcomes (3)

• Rate and direction of Adjustement in Medical Therapy

  During the 30 days

• Differences in Echocardiographic extracted strain pre and post study period

  Day 1 and day 30

• Score of Patient Experience

  At day 30

Study Arms (1)

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

Interventions

Continuous monitroing OTHER

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

Heart Failure Participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• NYHA Class II or higher
• years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead
• Aalborg University Hospital: collaborator
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (2)

Aalborg University Hospital

Aalborg, Denmark, 9000, Denmark

RECRUITING

Copenhagen University Hospital Herlev

Herlev, Denmark, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Samuel Schmidt, MSc, PhD

CONTACT

+4599407456; sschmidt@hst.aau.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: March 20, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)