Chronic Heart FailureRETENTIONNCT07008729
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
A study testing Heart monitoring tools (data revision) in people with Chronic Heart Failure and Heart Transplant Recipient, run by Puerta de Hierro University Hospital at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Heart Failure, Heart Transplant Recipient, Left Ventricular Assist Device
- What is being tested?
- Heart monitoring tools (data revision)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 24 Apr 2024to 30 Nov 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Greece2 sites
National and Kapodistrian University of Athens
Athens
Onassis Cardiac Surgery Center
Athens
Spain2 sites
Hospital Universitario Ramón Y Cajal
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
About this study
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.
Read more
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.
Read the detailed description
Specifically, the devices that will be given to the patients and their required use will be as follows:
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.
- Being tested
- Heart monitoring tools (data revision), Control (Standard treatment)
- Keywords
- Remote patient management, Telemonitoring, Chronic heart failure, Heart transplant, durable left ventricular assist device, hospitalisations, heart failure decompensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart monitoring tools (data revision)Device
data collected by the devices will be reviewed by the treating physician in the 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days lost due to unplanned cardiovascular hospitalization or all-cause death
Percentage of follow-up days lost due to CEC-adjudicated unplanned cardiovascular hospitalization or death from any cause, from randomization through the common 12-month horizon, comparing the remote patient monitoring and interventions (RPMI) group with the remote patient monitoring and usual care (RPMUC) group. Computed as 100 x days lost / days under observation through 12 months; after death, all remaining days to the 12-month horizon are counted as lost.
Measured: From randomization through the common 12-month analysis horizon
Secondary outcomes (17)
Rates of all-cause mortality
Measured: From enrollment to the end of follow-up (18 months, full individual follow-up); also analysed with administrative censoring at 12 months
Rates of cardiovascular mortality
Measured: From enrollment to the end of follow-up (18 months, full individual follow-up); also analysed with administrative censoring at 12 months
Differences in time to first unplanned HF hospitalization
Measured: From the enrollment to the end of the follow up (18 months)]
Differences in time to first unplanned cardiovascular hospitalization
Measured: From the enrollment to the end of the follow up (18 months)]
Rate of total unplanned HF hospitalizations
Measured: From the enrollment to the end of the follow up (18 months)
Rate of total unplanned cardiovascular hospitalizations
Measured: From the enrollment to the end of the follow up (18 months)
Differences in days lost due to HF hospitalizations
Measured: From the enrollment to the end of the follow up (18 months)]
Differences in the number of Smart device alarm notifications
Measured: From the enrollment to the end of the follow up (18 months)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Change from baseline to the month 12 visit. KCCQ from 0-100
Measured: Baseline and month 12
Change in the levels of NT-proBNP
Between Baseline and last visit
Measured: Baseline and month 12
Change in the Depression Score Patient Health Questionnaire 9 (PHQ-9)
Between baseline and last visit
Measured: Baseline and month 12
Change in the Heart Failure Caregiver Questionnaire (HF-CQ version 5.0)
Between baseline and last visit
Measured: Baseline and month 12
Difference in the rate of rejection needing treatment in heart transplant patients
Measured: From the enrollment to the end of the follow up (18 months)
Driveline infection needing antibiotic in left ventricular assist device (LVAD) patients
Measured: From the enrollment to the end of the follow up (18 months)
Differences in the rate of unplanned visit for heart failure requiring intravenous diuretics
Measured: From the enrollment to the end of the follow up (18 months)
Difference in the number of visits outside the protocol
Measured: From the enrollment to the end of the follow up (18 months)
Time to first unplanned cardiovascular hospitalization or all-cause death
Time from randomization to the first occurrence of unplanned cardiovascular hospitalization or death from any cause, whichever occurs first, comparing RPMI vs RPMUC.
Measured: Up to 18 months (full individual follow-up); also analysed with administrative censoring at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start24 Apr 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School, Attikon Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Onassis Cardiac Surgery Centre, Hospital Universitario Ramon y Cajal
- Responsible party
- Principal investigator, Mercedes Rivas-Lasarte, Puerta de Hierro University Hospital
- Investigators
- Maria Haritou, PhD, Study chair, ICCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008729
- Sponsor's protocol ID
- H2020-SC1-BHC-2018-2020 GA 965
- Other IDs
- PI 152/22
- Acronym
- RETENTION
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 30419185Ski 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.
PubMed 32558251McConnell 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.
PubMed 29880130Dorsey 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.
PubMed 27119325Liu 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.
PubMed 27185508Goswami 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.
PubMed 33938466Shahbazi 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.
PubMed 26344584Tripoliti 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.
PubMed 27942354Bennett 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.
PubMed 26670209Yun 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.
PubMed 28939459Savarese 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.
PubMed 28785469Ong 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
- ClinicalTrials.gov ID
- NCT07008729
- Acronym / sponsor ID
- RETENTION / H2020-SC1-BHC-2018-2020 GA 965
- Keywords
- Remote patient management, Telemonitoring, Chronic heart failure, Heart transplant, durable left ventricular assist device, hospitalisations, heart failure decompensation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Collaborators
- Hannover Medical School, Attikon Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Onassis Cardiac Surgery Centre, Hospital Universitario Ramon y Cajal
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Jun 2025 (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 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.
Detailed description
Specifically, the devices that will be given to the patients and their required use will be as follows:
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Heart monitoring tools (data revision)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. |
| Control group | Placebo comparator | Other: Control (Standard treatment)Patients in the control group will be monitored but the data will not be available to the clinicians nor the artificial intelligence recommendations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Heart monitoring tools (data revision)data collected by the devices will be reviewed by the treating physician in the intervention group | Device | 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 | Other | Control group |
Primary outcome
Percentage of days lost due to unplanned cardiovascular hospitalization or all-cause death
Time frame: From randomization through the common 12-month analysis horizon
Percentage of follow-up days lost due to CEC-adjudicated unplanned cardiovascular hospitalization or death from any cause, from randomization through the common 12-month horizon, comparing the remote patient monitoring and interventions (RPMI) group with the remote patient monitoring and usual care (RPMUC) group. Computed as 100 x days lost / days under observation through 12 months; after death, all remaining days to the 12-month horizon are counted as lost.
17 secondary outcomes
Rates of all-cause mortality
Time frame: From enrollment to the end of follow-up (18 months, full individual follow-up); also analysed with administrative censoring at 12 months
Rates of cardiovascular mortality
Time frame: From enrollment to the end of follow-up (18 months, full individual follow-up); also analysed with administrative censoring at 12 months
Differences in time to first unplanned HF hospitalization
Time frame: From the enrollment to the end of the follow up (18 months)]
Differences in time to first unplanned cardiovascular hospitalization
Time frame: From the enrollment to the end of the follow up (18 months)]
Rate of total unplanned HF hospitalizations
Time frame: From the enrollment to the end of the follow up (18 months)
Rate of total unplanned cardiovascular hospitalizations
Time frame: From the enrollment to the end of the follow up (18 months)
Differences in days lost due to HF hospitalizations
Time frame: From the enrollment to the end of the follow up (18 months)]
Differences in the number of Smart device alarm notifications
Time frame: From the enrollment to the end of the follow up (18 months)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Time frame: Baseline and month 12
Change in the levels of NT-proBNP
Time frame: Baseline and month 12
Change in the Depression Score Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline and month 12
Change in the Heart Failure Caregiver Questionnaire (HF-CQ version 5.0)
Time frame: Baseline and month 12
Difference in the rate of rejection needing treatment in heart transplant patients
Time frame: From the enrollment to the end of the follow up (18 months)
Driveline infection needing antibiotic in left ventricular assist device (LVAD) patients
Time frame: From the enrollment to the end of the follow up (18 months)
Differences in the rate of unplanned visit for heart failure requiring intravenous diuretics
Time frame: From the enrollment to the end of the follow up (18 months)
Difference in the number of visits outside the protocol
Time frame: From the enrollment to the end of the follow up (18 months)
Time to first unplanned cardiovascular hospitalization or all-cause death
Time frame: Up to 18 months (full individual follow-up); also analysed with administrative censoring at 12 months
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 30 Oct 2026.
- Background: PubMed 30419185Scott 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.
- Background: PubMed 32558251Ski 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.
- Background: PubMed 29880130McConnell 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.
- Background: PubMed 27119325Dorsey 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.
- Background: PubMed 27185508Liu 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.
- Background: PubMed 33938466Goswami 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.
- Background: PubMed 26344584Shahbazi 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.
- Background: PubMed 27942354Tripoliti 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.
- Background: PubMed 26670209Bennett 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.
- Background: PubMed 28939459Yun 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.
- Background: PubMed 28785469Savarese 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.
- 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.
- Oficial project's web site. It provides information about the project to every user.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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.
Maria Haritou, PhD study chair
ICCS
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart monitoring tools (data revision) in people with Chronic Heart Failure and Heart Transplant Recipient, run by Puerta de Hierro University Hospital at 6 sites in 4 countries.
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 8 inclusion and 9 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece, Spain, Germany, Italy. 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. Some participants in this study may receive a placebo. 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?
Percentage of days lost due to unplanned cardiovascular hospitalization or all-cause death (time frame: From randomization through the common 12-month analysis horizon). 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 NCT07008729, which also lists 12 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 30 Oct 2026.