Telemonitoring of HFrEF Patients
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Lodz, 폴란드, 92-213
- 2nd Department of Cardiology, Medical University of Lodz, Poland
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Intervention (telemonitoring) group
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. |
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.
다른 이름들:
|
|
간섭 없음: Control group
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The incidence of death
기간: From enrollment to the end of follow-up at 3 months
|
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
기간: 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. |
From enrollment to the end of follow-up at 3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The number of participants with jugular vein congestion
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
The presence or not of the jugular vein congestion, assessed dichotomously (present/absent) on physical examination both in the study and the control group. |
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
기간: At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
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 |
At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
|
The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) outcomes
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
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). |
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
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
The presence or not of the lung crepitations, assessed dichotomously (present/absent) on physical examination both in the study and the control group. |
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
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
The presence or not of the pleural effusion, assessed dichotomously (present/absent) on physical examination both in the study and the control group. |
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
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
The presence or not of the peripheral edema, assessed dichotomously (present/absent) on physical examination both in the study and the control group. |
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
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
The presence or not of the hepatomegaly, assessed dichotomously (present/absent) on physical examination both in the study and the control group. |
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
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
The presence or not of the ascites, assessed dichotomously (present/absent) on physical examination both in the study and the control group. |
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
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
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. |
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
기간: At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
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 |
At study visits: visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
|
The Visual Analogue Scale (VAS) outcomes
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
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. |
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
기간: At each study visit: visit 1 (day 0), visit 2 (day 30), visit 3 (day 60), visit 4 (day 90)
|
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. |
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
기간: At visit 1 (day 0)
|
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. |
At visit 1 (day 0)
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in the results of heart rate measured in the study group using the wristbands
기간: 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
|
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. |
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
기간: 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
|
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. |
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
기간: 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
|
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. |
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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jarosław Drożdż, 2nd Department of Cardiology, Medical University of Lodz, Poland
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- RNN/23/20/KE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data will be shared in a public repository with all sensitive personal data made confidential.
IPD 공유 기간
Until the end of 2028
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .