An interventional study of Telemonitoring wristband in Heart Failure and Heart Failure With Reduced Ejection Fraction (HFrEF), sponsored by Medical University of Lodz. Active, not recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Medical University of Lodz · Not applicable, Interventional, and Diagnostic
The aim of this study is to find out whether remote health monitoring can help people with chronic heart failure.
For 3 months, some patients use a SiDLY CARE PRO electronic wristband. It measures their physical activity, blood oxygen level and heart rate every 15 minutes. The information is sent electronically to a secure database.
The study includes two groups of patients. One group uses the wristband and receives regular cardiology care. The other group receives regular care without remote monitoring.
During the study, patients have three visits at the cardiology clinic. Their health, heart failure symptoms and treatment are assessed. They also complete short questionnaires about their quality of life and ability to perform everyday activities. The researchers compare the two groups to see whether remote monitoring is associated with better health and fewer hospital stays or deaths related to worsening heart failure.
The study began in February 2023 and is planned to continue until 31 December 2028.
The aim of this study is to observe the impact of the 3-month telemonitoring intervention using an electronic wristband measuring physical activity, peripheral capillary oxygen saturation and heart rate (HR) in the population of clinically stable patients with chronic heart failure with reduced ejection fraction (HFrEF), compared with the control group of patients not undergoing this intervention.
The participants are recruited in the Clinical Ward of Cardiology and the outpatient cardiology clinic of the Central Teaching Hospital of the Medical University of Lodz, Poland. During the preliminary phase of the study (Frebruary 2023-May 2024) patients were consecutively recruited to the study arm, followed by the recruitment of patients to the control arm.
During the first study visit, the patients in the intervention group received an electronic wearable wristband SiDLY CARE PRO, which monitored their physical activity, peripheral capillary oxygen saturation and heart rate, taking measurements at 15-minute intervals and transmitting the results to a database. All the participants from both the study and the control group received standard care at the cardiology clinic. The study period covered the following 3 months, during which each patient underwent 3 outpatient visits. During each visit, a physical examination was performed, the history of medical events, a potential exacerbation of heart failure and possible changes in pharmacotherapy was obtained, and the following patient's functional assessment scales were completed: the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12), the Visual Analogue Scale (VAS) and the 6 Activities of Daily Living Scale (6ADL). At V1, the Timed Up and Go Test (TUG) was also performed.
In both groups participating in the study, the incidence of a composite endpoint defined as death or hospitalisation for acute decompensated heart failure, its two components separately, HF-related hospitalisation equivalents as well as selected physical parameters and the results of the validated questionnaires mentioned above were analysed. In the study group, the data obtained by the telemonitoring wristbands were also analysed in subgroups specified on the basis of the time since the initiation of the intervention, the results of the KCCQ-12 and the occurrence of a composite endpoint.
After the initial phase of the study and acquisition of preliminary results, the prolongation of the study is planned until the 31st of December 2028 using the same protocol as the initial phase.
Exclusion Criteria:
At the first study visit the study group received an electronic wearable wristband SiDLY CARE PRO (SiDLY, Poland; medical device CE 0197 marking) measuring HR, peripheral capillary oxygen saturation and number of steps at 15-minute intervals. The data were transmitted remotely to an online database during the follow-up. The follow-up included three outpatient visits with a frequency of once every 30 ± 3 days. During the visits, the participants of the study group received standard care and feedback on the telemonitoring data.
Device: Telemonitoring wristband
The control group had the same number of follow-up visits during the study, but received no devices and thus, no feedback on telemonitoring data. After the study enrollment, the follow-up included three outpatient visits with a frequency of once every 30 ± 3 days. During the visits, the participants of the control group received standard care.
The intervention includes wearing an electronic wearable wristband SiDLY CARE PRO (SiDLY, Poland; medical device CE 0197 marking) for the study period of 3 months. The device monitors physical activity (pedometer), peripheral capillary oxygen saturation and heart rate, taking measurements at 15-minute intervals and transmitting the results to a database. Each user of the device receives an instruction regarding its proper use and battery loading.
Also known as: Electronic wristband, Telemonitoring
The incidence of death
The incidence of death assessed in both study and control group
Time frame: From enrollment to the end of follow-up at 3 months
The incidence of hospitalisation for acute decompensated heart failure or its equivalent
The incidence of hospitalisation for acute decompensated heart failure or its equivalent will be assessed in both study and control arm. The equivalent of hospitalisation is defined as the need for intravenous diuretic therapy, intravenous catecholamine infusion or passive oxygen therapy.
Time frame: From enrollment to the end of follow-up at 3 months
The number of participants with jugular vein congestion
The presence or not of the jugular vein congestion, assessed dichotomously (present/absent) on physical examination both in the study and the control group.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants who needed an oral cardiac pharmacotherapy dose escalation
The necessity for oral cardiac pharmacotherapy dose escalation defined as any uptitration of beta-adrenoceptor antagonists, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers or calcium channel blockers since the previous study visit and/or at the ongoing visit, assessed in both control and study group
Time frame: At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) outcomes
Completing the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) in both study and control group. The KCCQ-12 is a validated tool to assess the health status of HF patients, consisting of four domains evaluating physical limitations, the frequency of symptoms, social limitations and the quality of life. Each domain can range from 0 to 100 points, with higher scores indicating better health (fewer symptoms, fewer social and physical limitations, a better quality of life). The scores from each domain are transformed according to a predefined algorithm to derive an overall score (0-100).
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants with lung crepitations
The presence or not of the lung crepitations, assessed dichotomously (present/absent) on physical examination both in the study and the control group.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants with pleural effusion
The presence or not of the pleural effusion, assessed dichotomously (present/absent) on physical examination both in the study and the control group.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants with peripheral edema
The presence or not of the peripheral edema, assessed dichotomously (present/absent) on physical examination both in the study and the control group.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants with hepatomegaly
The presence or not of the hepatomegaly, assessed dichotomously (present/absent) on physical examination both in the study and the control group.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants with ascites
The presence or not of the ascites, assessed dichotomously (present/absent) on physical examination both in the study and the control group.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants with orthopnea
The presence or not of the orthopnea, assessed dichotomously (present/absent) on the medical history-taking from participant both in the study and the control group.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The number of participants who needed an oral diuretic initiation or dose escalation
The necessity for oral diuretic initiation or dose escalation since the previous study visit and/or at the ongoing visit, assessed in both control and study group
Time frame: At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The Visual Analogue Scale (VAS) outcomes
Completing the Visual Analogue Scale (VAS) in both study and control group. The VAS consists of a 20-cm vertical axis with evenly spaced points ranging from 0 to 100. Patients were asked to indicate how well or poorly they perceived their overall health status at the time of assessment. A score of 0 represented the worst health state imaginable to the patient, whereas a score of 100 represented the best imaginable health state.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The 6 Activities of Daily Living Scale (6ADL) outcomes
Completing the 6 Activities of Daily Living Scale (6ADL) in both study and control group. The 6ADL is a validated tool used to assess patients' independence or dependence in six activities of daily living: personal hygiene, dressing, toileting, mobility within the home, bladder and bowel continence, and feeding. The patient receives one point for each activity that they are able to perform independently. The total score constitutes the Katz Index, ranging from 0 to 6 points, with a score of 6 indicating complete independence and a score of 0 indicating complete dependence.
Time frame: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The Timed Up and Go Test (TUG) outcomes
Completing the Timed Up and Go Test (TUG)) in both study and control group. The TUG test is a tool used to assess the risk of falls in older adults. It measures, in seconds, the time required for a patient to rise from a seated position, walk three metres at their usual pace, turn around, return to the chair, and sit down again. Higher TUG times have been observed in older patients and in those with poorer quality of life and a more severe course of heart failure, a higher risk of balance impairment.
Time frame: At visit 1 (day 0)
Change in the results of heart rate measured in the study group using the wristbands
Comparison of the mean/median circadian results of heart rate measured in the study group with the use of telemonitoring wristbands, in relation to the time from the beginning of the intervention.
Time frame: Comparison of the periods between the study visits: visit 1-visit 2 (day 0-day 30), visit 2-visit 3 (day 30-day 60), visit 3-visit 4 (day 60-day 90) performed after the completion of the observation
Change in the results of peripheral capillary oxygen saturation measured in the study group using the wristbands
Comparison of the mean/median circadian results of peripheral capillary oxygen saturation measured in the study group with the use of telemonitoring wristbands, in relation to the time from the beginning of the intervention.
Time frame: Comparison of the periods between the study visits: visit 1-visit 2 (day 0-day 30), visit 2-visit 3 (day 30-day 60), visit 3-visit 4 (day 60-day 90) performed after the completion of the observation
Change in the results of daily number of steps taken measured in the study group using the wristbands
Comparison of the mean/median results of daily number of steps taken measured in the study group with the use of telemonitoring wristbands, in relation to the time from the beginning of the intervention.
Time frame: Comparison of the periods between the study visits: visit 1-visit 2 (day 0-day 30), visit 2-visit 3 (day 30-day 60), visit 3-visit 4 (day 60-day 90) performed after the completion of the observation
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data will be shared in a public repository with all sensitive personal data made confidential.
Supporting information: Study protocol
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Medical University of Lodz