Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
NCT ID: NCT07008729
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
390 participants
INTERVENTIONAL
2024-04-24
2026-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The ultimate goal is to reduce mortality and hospitalization rates for this group of patients while improving their quality of life, safety, and well-being.
To do this, participants will be divided into two groups:
* Intervention Group: The data collected by the platform will be available to their treating doctors.
* Control Group: Doctors will not have access to the data.
All participating patients will receive a set of devices and sensors to collect data such as vital signs, physical activity, sleep quality, psychological and nutritional status, and environmental data. All this information will be gathered through a mobile app designed for the study.
The follow-up will last for 18 months, during which there will be 4 in-person medical visits (spaced 4 months apart). Participation in the study won't affect patients' scheduled medical visits related to their illness or their usual treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices
NCT06909682
Daily Ambulatory Remote Monitoring System For Post-Dischage Management Of ADHF
NCT03072693
The Cardio-share Telemedicine Cross-sector Collaboration Model for Managing Vulnerable Patients With Heart Failure
NCT06176131
Telemedical Interventional Management in Heart Failure II
NCT01878630
Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial
NCT04210167
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A Smartphone: This will have the app with the platform designed for the study. The patient must interact with it daily to enter data.
A Blood Pressure Monitor: The patient will need to take their blood pressure every day and send it via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients).
An Oxygen Saturation Monitor: The patient will need to check their oxygen levels daily and send the data via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients).
A Scale: The patient will need to weigh themselves daily and transmit the data via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients).
A Smartwatch: The patient must send data on their physical activity and sleep daily via Bluetooth to the mobile platform (the connection setup will be done by the study team before giving it to the patients).
Home Humidity and Temperature Sensors and a Home Gateway Device (Raspberry Pi): The patient will need to connect this last device to their home internet network. The connection setup will be done by the study team before giving it to the patients.
There are other data and information that the patient must manually enter into the app, such as daily body temperature, symptoms they experience (like increased fatigue or shortness of breath), or data on the functioning of the long-term ventricular assistance (controller parameters or alarm presence). Additionally, the app will show the patient's current medication, which they need to confirm they have taken correctly.
The scheduled visits during the study will take place at the Baseline and every four months. These visits will include an in-person medical visit, an electrocardiogram, a blood test, and a 6-minute walk test. Also, at each visit, a series of questionnaires will be given to assess the patient's cognitive, nutritional, and psychological state, as well as their quality of life and that of their primary caregivers. Some visits will also include more specific cardiac tests, like an echocardiogram or a cardiopulmonary exercise test.
If during the study follow-up, the treating doctors unexpectedly discover any information that affects the patient's health or quality of life, the patient will be informed immediately, even if it is unrelated to the study's purpose.
All data recorded throughout the study will be stored anonymously by the study platform.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
The RETENTION platform will offer to the clinician in the experimental arm all the data gathered by the devices (smart watch, scale, oximeter, blood pressure monitor, temperature, medication adherence, weather and pollution indexes). along with artificial intelligence recommendations.
Heart monitoring tools (data revision)
data collected by the devices will be reviewed by the treating physician in the intervention group
Control group
Patients in the control group will be monitored but the data will not be available to the clinicians nor the artificial intelligence recommendations.
Control (Standard treatment)
Patients in the control group will be monitored but the information will not be available for the clinicians nor the artificial intelligence recommendations
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Heart monitoring tools (data revision)
data collected by the devices will be reviewed by the treating physician in the intervention group
Control (Standard treatment)
Patients in the control group will be monitored but the information will not be available for the clinicians nor the artificial intelligence recommendations
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to understand and provide consent in order to participate in the study.
* Have a cognitive assessment score of \> 22 as assessed by the Montreal Cognitive Assessment (MoCA), ( adults without or with mild cognitive impairment at most).
* Have a depression score as assessed by Personal Health Questionnaire-9 (PHQ-9) score \< 10.
* Provide written informed consent.
* For Heart Failure patients: 1) have a diagnosis of symptomatic heart failure (class II or III according to the New York Heart Association Classification); 2) have echocardiographically determined left ventricular ejection fraction (LVEF) ≤40%; 3) have been hospitalized due to cardiovascular reasons or had urgent visit to the Emergency Department due to decompensated HF that required administration of intravenous diuretics within the last 12 months before randomization (Currently hospitalized patients can be included provided they do not fulfill exclusion criterion of being currently with in-hospital administration of IV diuretics/vasoactive/inotropic drugs).
* For patients with ventricular assist devices (VAD): have left ventricular assist device (LVAD) implanted either as destination therapy or as bridge-to-transplantation, within at least 90 days and no longer than 48 months before randomization
* for heart transplant recipients: have been discharged following heart transplantation within at least 30 days and no longer than 36 months before study randomization.
Exclusion Criteria
* Has acute coronary syndrome within the last 30 days before randomization.
* Has acute inflammatory heart disease, (for instance, acute myocarditis), within 90 days prior to randomization.
* Has a planned revascularisation, cardiac resynchronization therapy (CRT) implantation or any valvular procedures within 3 months after randomization
* Has known current alcohol or illicit drug abuse.
* Shows significant impairment or unwillingness to use the telemonitoring equipment (for instance, dementia, impaired self-determination, lacking ability to communicate).
* Has any severe non-cardiovascular disease limiting life expectancy to less than 1 year.
* Is pregnant.
* Participates currently in other telemonitoring programs/studies using smart devices
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hannover Medical School
OTHER
Attikon Hospital
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Onassis Cardiac Surgery Centre
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Puerta de Hierro University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mercedes Rivas-Lasarte
Principal Investigator, MD PHD, Cardiology Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria Haritou, PhD
Role: STUDY_CHAIR
ICCS
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Hochschule Hannover ('Mhh')
Hanover, , Germany
National and Kapodistrian University of Athens
Athens, , Greece
Onassis Cardiac Surgery Center
Athens, , Greece
Alma Mater Studiorum - Universita Di Bologna
Bologna, , Italy
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Ramón Y Cajal
Madrid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bennett MK, Shao M, Gorodeski EZ. Home monitoring of heart failure patients at risk for hospital readmission using a novel under-the-mattress piezoelectric sensor: A preliminary single centre experience. J Telemed Telecare. 2017 Jan;23(1):60-67. doi: 10.1177/1357633X15618810. Epub 2016 Jul 9.
Scott IA, Scuffham P, Gupta D, Harch TM, Borchi J, Richards B. Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. Aust Health Rev. 2020 Feb;44(1):62-82. doi: 10.1071/AH18064.
Ski CF, Thompson DR, Brunner-La Rocca HP. Putting AI at the centre of heart failure care. ESC Heart Fail. 2020 Oct;7(5):3257-3258. doi: 10.1002/ehf2.12813. Epub 2020 Jun 17. No abstract available.
McConnell MV, Turakhia MP, Harrington RA, King AC, Ashley EA. Mobile Health Advances in Physical Activity, Fitness, and Atrial Fibrillation: Moving Hearts. J Am Coll Cardiol. 2018 Jun 12;71(23):2691-2701. doi: 10.1016/j.jacc.2018.04.030.
Dorsey ER, Yvonne Chan YF, McConnell MV, Shaw SY, Trister AD, Friend SH. The Use of Smartphones for Health Research. Acad Med. 2017 Feb;92(2):157-160. doi: 10.1097/ACM.0000000000001205.
Liu L, Stroulia E, Nikolaidis I, Miguel-Cruz A, Rios Rincon A. Smart homes and home health monitoring technologies for older adults: A systematic review. Int J Med Inform. 2016 Jul;91:44-59. doi: 10.1016/j.ijmedinf.2016.04.007. Epub 2016 Apr 19.
Goswami R. The current state of artificial intelligence in cardiac transplantation. Curr Opin Organ Transplant. 2021 Jun 1;26(3):296-301. doi: 10.1097/MOT.0000000000000875.
Shahbazi F, Asl BM. Generalized discriminant analysis for congestive heart failure risk assessment based on long-term heart rate variability. Comput Methods Programs Biomed. 2015 Nov;122(2):191-8. doi: 10.1016/j.cmpb.2015.08.007. Epub 2015 Aug 24.
Tripoliti EE, Papadopoulos TG, Karanasiou GS, Naka KK, Fotiadis DI. Heart Failure: Diagnosis, Severity Estimation and Prediction of Adverse Events Through Machine Learning Techniques. Comput Struct Biotechnol J. 2016 Nov 17;15:26-47. doi: 10.1016/j.csbj.2016.11.001. eCollection 2017.
Yun JE, Park JE, Park HY, Lee HY, Park DA. Comparative Effectiveness of Telemonitoring Versus Usual Care for Heart Failure: A Systematic Review and Meta-analysis. J Card Fail. 2018 Jan;24(1):19-28. doi: 10.1016/j.cardfail.2017.09.006. Epub 2017 Sep 20.
Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Oficial project's web site. It provides information about the project to every user.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PI 152/22
Identifier Type: OTHER
Identifier Source: secondary_id
H2020-SC1-BHC-2018-2020 GA 965
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.