Heart FailureHeart Failure With Reduced Ejection Fraction (HFrEF)
Investigational drug(s) / intervention(s)
Telemonitoring wristband
Telemonitoring wristband: 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* provided written informed consent prior to any study specific procedures;
* males and females aged \>18 years old at the time of consent;
* documented diagnosis of HFrEF prior to enrollment and optimally treated with pharmacological and/or device therapy;
* left ventricular ejection fraction ≤40% in a transthoracic echocardiogram from the last 12 months before recruitment;
* NYHA class II-III.
Exclusion Criteria:
* acute or decompensated heart failure;
* the primary cause of heart failure in the form of active myocarditis, constrictive pericarditis or a valvular heart disease that has not been treated by interventional or surgical means, as defined by the ESC guidelines;
* myocardial infarction, unstable angina, stroke or transient ischemic attack, coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft, valve replacement surgery or ICD/CRT implantation within 4 weeks prior to study enrollment;
* planned coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft;
* planned valve replacement surgery;
* status after heart transplantation;
* symptomatic bradycardia or third-degree atrioventricular block without a pacemaker;
* a severe non-cardiovascular disease with a life expectancy of less than 1 year, or a patient condition precluding the performance of the procedures specified in the study protocol;
* diagnosis of malignancy at the time of screening;
* history of an allergic reaction to materials contained in the wristband.
Primary outcome measure(s)
The incidence of death — From enrollment to the end of follow-up at 3 months The incidence of death assessed in both study and control group
The incidence of hospitalisation for acute decompensated heart failure or its equivalent — From enrollment to the end of follow-up at 3 months 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.
Trial sites (1)
Facility
City
Region
Status
2nd Department of Cardiology, Medical University of Lodz, Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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