Heart failure Heart failure
Conditions
Interventions
Twenty adult patients admitted with decompensated heart failure will wear the Health Patch continuously during hospitalization. Clinical care will not be influenced by device data. 
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Age =18 yearsAdmitted to LUMC with decompensated HFAdmission occurred <36 hours prior to inclusionClinically assessed “warm and wet” HF phenotype, defined as:signs of congestion/fluid overload, andhemodynamic stability without shock or clinical signs of hypoperfusionSufficient language proficiency in Dutch to understand study information and provide informed consentAble and willing to comply with study procedures until dischargeAble to provide written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria A potential participant who meets any of the following criteria will be excluded from participation in this study:Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m²Planned, scheduled, or highly likely cardiac intervention during the index hospitalization (e.g., percutaneous coronary intervention (PCI), cardiac surgery, ablation) that may interfere with study procedures or monitoringPresence of a cardiac implantable electronic deviceComplex congenital heart diseaseMechanical circulatory support (e.g., Left Ventricular Assist Device (LVAD), Impella, Extracorporeal membrane oxygenation (ECMO))Concurrent participation in another study Wounded or particular sensitive skin. For example, skin-rash, discoloration, scars, or open wounds at area of investigationKnown to be allergic to silicones or acrylics, or medical gelsUse of medication known to influence the skin at the test area (such as medical creams of lotions).Any other condition that, in the opinion of the investigator, makes participation unsuitable or burdensome (e.g., inability to cooperate with patch wear)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the longitudinal multivariate physiological trajectory obtained during hospitalization for decompensated heart failure. Thoracic impedance will be measured at multiple frequencies (5, 8, 10, 13, 16, 20, 26, 40, 80, 160, 200, and 500 kHz) using the HSP4 wearable patch during repeated measurement sessions throughout admission during dynamic changes in fluid status. Additionally ECG-derived parameters, respiratory metrics and accelerometry-derived measurements will be obtained. Measurements are obtained during twice-daily 30-minute recording sessions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Multi-signal qualityFor each participant, signal quality, including missing data patterns, will be assessed for the following (derived) parameters recorded by the HSP4: Thoracic impedanceSingle-lead ECGHeart rate (including nocturnal heart rate)Heart rate variabilityRespiratory parameters (rate, depth, variability)Accelerometry-derived activity metricsPosture estimationSafety and tolerabilityDevice-related adverse events will be documented, including skin irritation, allergic reactions, discomfort, patch detachment, and any premature discontinuation of patch wear due to intolerance.Patient tolerability will include the number of patch replacements required during admission, completion of patch wear until discharge and description of reasons for interruption or early removal.Patient experiencePatient experience with patch wear will be assessed by a single, brief, non-intrusive questionnaire that does not compromise patients’ psychological well-being and requires minimal time to complete | — |
Countries
Netherlands
Contacts
Public ContactM Nederend
Leids Universitair Medisch Centrum
Outcome results
None listed