Heart FailureNCT07835490

Telemonitoring of HFrEF Patients

A study testing Telemonitoring wristband in people with Heart Failure and Heart Failure With Reduced Ejection Fraction (HFrEF), run by Medical University of Lodz at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)
What is being tested?: Telemonitoring wristband
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 sitePoland
Study dates: 21 Feb 2023to 31 Dec 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

2nd Department of Cardiology, Medical University of Lodz, Poland
Lodz, 92-213

Other trials in Poland

About this study

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

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.

Read the detailed description

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.

Conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF)
Being tested: Telemonitoring wristband
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
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telemonitoring wristbandDevice
Also called Electronic wristband, Telemonitoring
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 groups in NCT07835490
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of death
The incidence of death assessed in both study and control group
Measured: 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.
Measured: From enrollment to the end of follow-up at 3 months

Secondary outcomes (13)

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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At visit 1 (day 0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 202331 Dec 2028

First posted23 Sep 2026
Study start21 Feb 2023
Primary completion4 May 2024
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: First group of patients were consecutively recruited to the study arm, than second group of patients were consecutively recruited to the control arm.
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07835490
Sponsor's protocol ID: RNN/23/20/KE
Status last verified: Sep 2026
First submitted: 4 Sep 2026
Last updated: 25 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The data will be shared in a public repository with all sensitive personal data made confidential.

Publications

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.
PubMed 31734701
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.
PubMed 21444883
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.
PubMed 26857383
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.
PubMed 22720184
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.
PubMed 21080835
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.
PubMed 27864319
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.
PubMed 28330835
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.
PubMed 21733889
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.
PubMed 29237746
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.
PubMed 30624588
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.
PubMed 34447992

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telemonitoring of Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
ClinicalTrials.gov ID: NCT07835490
Acronym / sponsor ID: RNN/23/20/KE
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
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 60 participants (actual)
Lead sponsor: Medical University of LodzUniversity, hospital or other
Study start: 21 Feb 2023 (actual)
Primary completion: 4 May 2024 (actual)
Study completion: 31 Dec 2028 (estimated)
First posted: 23 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to find out whether remote health monitoring can help people with chronic heart failure.

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.

The study began in February 2023 and is planned to continue until 31 December 2028.

Detailed description

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.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: First group of patients were consecutively recruited to the study arm, than second group of patients were consecutively recruited to the control arm.

Arm	Type	Receives
Intervention (telemonitoring) group	Experimental	Device: Telemonitoring wristbandAt 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.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telemonitoring wristbandAlso: Electronic wristband, TelemonitoringThe 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.	Device	Intervention (telemonitoring) group

Primary outcome

The incidence of death
Time frame: 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
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 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.

13 secondary outcomes

The number of participants with jugular vein congestion
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
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
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
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
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
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
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
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
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
Time frame: At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
The Visual Analogue Scale (VAS) outcomes
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
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
Time frame: At visit 1 (day 0)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Background: PubMed 31734701Piotrowicz 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.
Background: PubMed 21444883Koehler 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.
Background: PubMed 26857383Ong 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.
Background: PubMed 22720184Giamouzis 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.
Background: PubMed 21080835Chaudhry 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.
Background: PubMed 27864319Inglis 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.
Background: PubMed 28330835Lin 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.
Background: PubMed 21733889Inglis 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.
Background: PubMed 29237746Jayaram 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.
Background: PubMed 30624588Bottle 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.
Background: PubMed 34447992McDonagh 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.
Individual participant dataSharing planned: Yes. The data will be shared in a public repository with all sensitive personal data made confidential.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jarosław Drożdż principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telemonitoring wristband in people with Heart Failure and Heart Failure With Reduced Ejection Fraction (HFrEF), run by Medical University of Lodz at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of death (time frame: From enrollment to the end of follow-up at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07835490, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.