I50
Conditions
Interventions
Group 1: Patients with Congestive Heart Failure under continuous monitoring via monti®-Platform for 90 days
Sponsors
Medizinische Fakultät der RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Acute-decompensated heart failure confirmed within the last 24 hours - Age >= 18 years and able to understand design and objectives of the trial - Signed written informed consent and data safety agreement before any study-related activities - Willingness to wear the wearable during the treatment period and return it on a follow-up visit
Exclusion criteria
Exclusion criteria: - Active malignant disease - Pregnancy - Active severe systemic infection, defined as intravenous administration of antibiotics - End stage renal disease with dialysis - Medical or mental conditions, such as dementia, that hinder the continuous use of the monitoring platform and associated equipment during the monitoring period - Any condition that makes wearing the wearable device impossible (e.g., presence of a shunt, active bleeding, or absence of limbs) - Mental incapacity or language barriers which preclude adequate understanding or cooperation, known or suspected not to comply with study directives or not to be reliable or trustworthy, or subject who in the opinion of the investigator should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Calculating AUROC ("Area Under the Receiver Operating Characteristics curve") to assess the detection capabilities of episodes with ADHF by the self-supervised contrastive learning-derived risk index based on wearable recorded time series | — |
Secondary
| Measure | Time frame |
|---|---|
| - Assessing data integrity of the monti®-platform and quality of the mobile monti-app (mean % of wearable data per day, time difference between logged time point of measurement and database, score in Mobile App Rating Scale (MARS-G)) | — |
Countries
Germany
Contacts
Public ContactMalte Jacobsen
Medizinische Klinik I der Uniklinik RWTH Aachen
Outcome results
None listed