Telemonitoring of HFrEF Patients

NCT07835490 | Active Not Recruiting

• 1 other identifier: RNN/23/20/KE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction (HFrEF)

Keywords

heart failure; Kansas City Cardiomyopathy Questionnaire; quality of life; telemonitoring wristband; electronic wristband; telemedicine; prospective study; controlled study; single-center study; SiDLY CARE PRO wristband

Outcome Measures

Primary Outcomes (2)

• The incidence of death

  The incidence of death assessed in both study and control group

  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.

  From enrollment to the end of follow-up at 3 months

Secondary Outcomes (13)

• The number of participants with jugular vein congestion

  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

  At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)

• The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) outcomes

  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

  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

  At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)

Other Outcomes (3)

• Change in the results of heart rate measured in the study group using the wristbands

  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 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 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

Study Arms (2)

Intervention (telemonitoring) group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Telemonitoring wristband DEVICE

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

Intervention (telemonitoring) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

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

Lodz, 92-213, Poland

Location

Related Publications (11)

• Piotrowicz E, Pencina MJ, Opolski G, Zareba W, Banach M, Kowalik I, Orzechowski P, Szalewska D, Pluta S, Glowczynska R, Irzmanski R, Oreziak A, Kalarus Z, Lewicka E, Cacko A, Mierzynska A, Piotrowicz R. Effects of a 9-Week Hybrid Comprehensive Telerehabilitation Program on Long-term Outcomes in Patients With Heart Failure: The Telerehabilitation in Heart Failure Patients (TELEREH-HF) Randomized Clinical Trial. JAMA Cardiol. 2020 Mar 1;5(3):300-308. doi: 10.1001/jamacardio.2019.5006.

  PMID: 31734701 BACKGROUND

• Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28.

  PMID: 21444883 BACKGROUND

• Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.

  PMID: 26857383 BACKGROUND

• Giamouzis G, Mastrogiannis D, Koutrakis K, Karayannis G, Parisis C, Rountas C, Adreanides E, Dafoulas GE, Stafylas PC, Skoularigis J, Giacomelli S, Olivari Z, Triposkiadis F. Telemonitoring in chronic heart failure: a systematic review. Cardiol Res Pract. 2012;2012:410820. doi: 10.1155/2012/410820. Epub 2012 Jun 7.

  PMID: 22720184 BACKGROUND

• Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.

  PMID: 21080835 BACKGROUND

• Inglis SC, Clark RA, Dierckx R, Prieto-Merino D, Cleland JG. Structured telephone support or non-invasive telemonitoring for patients with heart failure. Heart. 2017 Feb 15;103(4):255-257. doi: 10.1136/heartjnl-2015-309191. Epub 2016 Nov 18. No abstract available.

  PMID: 27864319 BACKGROUND

• Lin MH, Yuan WL, Huang TC, Zhang HF, Mai JT, Wang JF. Clinical effectiveness of telemedicine for chronic heart failure: a systematic review and meta-analysis. J Investig Med. 2017 Jun;65(5):899-911. doi: 10.1136/jim-2016-000199. Epub 2017 Mar 22.

  PMID: 28330835 BACKGROUND

• Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG. Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review. Eur J Heart Fail. 2011 Sep;13(9):1028-40. doi: 10.1093/eurjhf/hfr039. Epub 2011 Jul 6.

  PMID: 21733889 BACKGROUND

• Jayaram NM, Khariton Y, Krumholz HM, Chaudhry SI, Mattera J, Tang F, Herrin J, Hodshon B, Spertus JA. Impact of Telemonitoring on Health Status. Circ Cardiovasc Qual Outcomes. 2017 Dec;10(12):e004148. doi: 10.1161/CIRCOUTCOMES.117.004148.

  PMID: 29237746 BACKGROUND

• Bottle A, Kim D, Hayhoe B, Majeed A, Aylin P, Clegg A, Cowie MR. Frailty and co-morbidity predict first hospitalisation after heart failure diagnosis in primary care: population-based observational study in England. Age Ageing. 2019 May 1;48(3):347-354. doi: 10.1093/ageing/afy194.

  PMID: 30624588 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

  PMID: 34447992 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jarosław Drożdż

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the 2nd Department of Cardiology, Medical University of Lodz, Poland

Model Details: First group of patients were consecutively recruited to the study arm, than second group of patients were consecutively recruited to the control arm.

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 23, 2026
• Study Start: February 21, 2023
• Primary Completion: May 4, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Until the end of 2028
• Access Criteria: The link to the data available in the public repository will be provided to researchers upon their written request to the designated contact persons, together with an explanation of the purpose for which the data are being requested and a description of the planned further processing of the data.

Locations

PL (1)