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ACTIVE NOT RECRUITING
NCT07835490
NA

Telemonitoring of HFrEF Patients

Sponsor: Medical University of Lodz

View on ClinicalTrials.gov

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.

Official title: Telemonitoring of Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-02-21

Completion Date

2028-12-31

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

2nd Department of Cardiology, Medical University of Lodz, Poland

Lodz, Poland