Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data

NCT07008729 | Active Not Recruiting

• 2 other identifiers: H2020-SC1-BHC-2018-2020 GA 965PI 152/22
• Study Type: interventional
• Target: 390
• Locations: 4 countries
• Sites: 6

Brief Summary

The goal of this study is to create a digital platform for managing patients with chronic heart failure, those with long-term ventricular assistance, or heart transplant recipients. This platform aims to help doctors make clinical decisions and change treatments based on continuous monitoring and the collection of medical, clinical, physiological, behavioral, psychosocial, and real-world data from these patients. 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.

Conditions

Chronic Heart Failure; Heart Transplant Recipient; Left Ventricular Assist Device

Keywords

Remote patient management; Telemonitoring; Chronic heart failure; Heart transplant; durable left ventricular assist device; hospitalisations; heart failure decompensation

Outcome Measures

Primary Outcomes (2)

• Difference in days lost due to unplanned cardiovascular hospitalizations or all-cause death between groups

  Comparison of days lost due to unplanned cardiovascular hospitalizations or all-cause death between groups

  From the enrollment to the end of the follow up (18 months)

• Differences in the rates of occurrence of death or unplanned hospitalization/ambulatory administration of intravenous (iv) diuretics, iv antibiotics or iv steroids

  Comparison of the rates of the occurrence of death or unplanned hospitalization/ambulatory administration of intravenous (iv) diuretics, iv antibiotics or iv steroids between groups

  From the enrollment to the end of the follow up (18 months)

Secondary Outcomes (16)

• Rates of all-cause mortality

  From the enrollment to the end of the follow up (18 months)

• Rates of cardiovascular mortality

  From the enrollment to the end of the follow up (18 months)]

• Differences in time to first unplanned HF hospitalization

  From the enrollment to the end of the follow up (18 months)]

• Differences in time to first unplanned cardiovascular hospitalization

  From the enrollment to the end of the follow up (18 months)]

• Rate of total unplanned HF hospitalizations

  From the enrollment to the end of the follow up (18 months)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Heart monitoring tools (data revision)

Control group

PLACEBO COMPARATOR

Patients in the control group will be monitored but the data will not be available to the clinicians nor the artificial intelligence recommendations.

Other: Control (Standard treatment)

Interventions

Heart monitoring tools (data revision) DEVICE

data collected by the devices will be reviewed by the treating physician in the intervention group

Intervention group

Control (Standard treatment) OTHER

Patients in the control group will be monitored but the information will not be available for the clinicians nor the artificial intelligence recommendations

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-75 years.
• 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 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.

You may not qualify if:

• Is clinically unstable at the time of randomization as defined by: administration of intravenous diuretics during the last 12 hours or intravenous vasodilators or inotropes during the last 48 hours before randomization.
• 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

Sponsors & Collaborators

• Attikon Hospital: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Onassis Cardiac Surgery Centre: collaborator
• Hannover Medical School: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Puerta de Hierro University Hospital: lead

Study Sites (6)

Medizinische Hochschule Hannover ('Mhh')

Hanover, Germany

Location

National and Kapodistrian University of Athens

Athens, Greece

Location

Onassis Cardiac Surgery Center

Athens, Greece

Location

Alma Mater Studiorum - Universita Di Bologna

Bologna, Italy

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Ramón Y Cajal

Madrid, Spain

Location

Related Publications (12)

• 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.

  PMID: 30419185 BACKGROUND

• 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.

  PMID: 32558251 BACKGROUND

• 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.

  PMID: 29880130 BACKGROUND

• 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.

  PMID: 27119325 BACKGROUND

• 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.

  PMID: 27185508 BACKGROUND

• 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.

  PMID: 33938466 BACKGROUND

• 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.

  PMID: 26344584 BACKGROUND

• 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.

  PMID: 27942354 BACKGROUND

• 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.

  PMID: 26670209 BACKGROUND

• 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.

  PMID: 28939459 BACKGROUND

• 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.

  PMID: 28785469 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

Related Links

• Oficial project's web site. It provides information about the project to every user.

Study Officials

• Maria Haritou, PhD

  ICCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The care providers will be masked to the data collected by the control group
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD PHD, Cardiology Department

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 6, 2025
• Study Start: April 24, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

ES (2); GR (2); DE (1); IT (1)