Heart Failure With Reduced Ejection Fraction(CAARdioRING)NCT06920160
Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
A study testing software Caaring (remote monitoring app) in people with Heart Failure With Reduced Ejection Fraction, run by Persei Vivarium at 2 sites in Spain.
Trial summary
The goal of this clinical trial investigation with device is to determinate the effectiveness of remote monitoring of patients with heart failure with reduced ejection fraction heart (EFS40%) using Caaring® software. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- software Caaring (remote monitoring app)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Apr 2025to Aug 2025
- 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
- Patients aged 18 years or older
- Patients diagnosed with heart failure with reduced ejection fraction (EFS40%)
- Patients discharged after an episode of acute heart failure and/or patients who are being followed up after being admitted for heart failure.
- Patients who extensively use a smartphone.
- lnformed Consent is obtained from the patient
Who cannot join
- Patients with cognitive ar sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions ar the scales, as long as they do not have a legally authorized representative capable of participating in the study.
- Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
- Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
- Patients whose main diagnosis is a poorly controlled mental disorders ar other medical illness.
- Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
- lnstitutionalized patients
- Patients who are pregnant ar breastfeeding.
- Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, 15405
Raquel Marzoa Rivas, PhD, +34 981334000, raquel.marzoa.rivas@sergas.es
Raquel Marzoa Rivas, PhD
- Recruiting
Hospital Universitario de Son Llatzer
Palma de Mallorca, Balearic Islands, 07198
José María Gámez Martínez, PhD, +34 871202000, jmgamez3@gmail.com
José María Gámez Martínez, PhD
About this study
Official title: Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
The goal of this clinical trial investigation with device is to determinate the effectiveness of remote monitoring of patients with heart failure with reduced ejection fraction heart (EFS40%) using Caaring® software.
The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with heart failure in the course of their disease will reduce the number of re-entries. For this, researchers will compare the assessments between the two groups.
Read more
This is a randomized study with two arms. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Prospective Control group: The data of these patients are collected prospectively for their routine medical visits for 12 weeks after their inclusion.
In addition, Control group patients must have clinical data from the 12 weeks after to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous monitoring devices.
Participants with heart failure will continue to receive conventional care and must have sufficient technological skills to use a smartphone.
Read the detailed description
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.
The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.
- Being tested
- software Caaring (remote monitoring app)
- Keywords
- Heart Failure, Reduced Ejection Fraction, DTx, Caaring, remote patients monitoring, Digital Health
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
software Caaring (remote monitoring app)Device
Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/ questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G_CAARING) will receive educational and prevention recommendations relative to Heart Faillure.
| Study group | Role | What they receive |
|---|---|---|
| Online telemonitoring group (G_CAARING) | Active comparator | The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. Receives: Device: software Caaring (remote monitoring app) |
| Control Group (G_Control) | No intervention | The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of re-entries in patients with heart failure
Number of re-entries in patients with heart failure
Measured: Day 0, Week 12
Secondary outcomes (7)
Changes in Health-related quality of life (WHOQOL)
Change in the patient's quality of life scale the study comparad to baseline: WHOQOL questionnaire (Value 0- 100). A higher score reflects a higher health-related quality of life.
Measured: Day 0, Week 12
Adherence treatment equal to or greater than 80%
Percentage of patients with treatment adherence for heart failure equal to or greater than 80%
Measured: Day 0 and Weekly up to 12 weeks
Changas in the patient's MEDAS scale: Adherence to Mediterranean Diet
Changes in patient's scale MEDAS (Mediterranean Diet Adherence Screener) scores at week 4 and at the end of the study compared to baseline. Values: 0-14, a higher score reflects a better adherence to the Mediterranean Diet.
Measured: Day 0, Week 12
Changes in the patient's Clinical Data
Changes in patient's Clinical data (symptoms related to heart failure) measured through a specific form created for this purpose.
Measured: Day O, every 3 days up to Week 12
Patient satisfaction with the software Caaring
The patient satisfaction will be measured through a specific satisfaction questionnaire created for this purpose. (Value 3-15). A higher score reflects greater satisfaction with software care.
Measured: Week 12
Changes in the patient's in Liquid Consumption
Changes in patient's Liquid Consumption Questionnaire. The changes will be measured through a specific form created for this purpose
Measured: Day 0, Week 12
Adherence treatment equal to 100%
Percentage of patients with treatment for heart failure adherence equal to 100%
Measured: Day 0 and Weekly up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Apr 2025
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Persei Vivarium
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920160
- Sponsor's protocol ID
- CAARdioRING
- Acronym
- (CAARdioRING)
- Status last verified
- Jun 2025
- First submitted
- 25 Mar 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
- ClinicalTrials.gov ID
- NCT06920160
- Acronym / sponsor ID
- (CAARdioRING) / CAARdioRING
- Keywords
- Heart Failure, Reduced Ejection Fraction, DTx, Caaring, remote patients monitoring, Digital Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Persei VivariumUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 9 Apr 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 clinical trial investigation with device is to determinate the effectiveness of remote monitoring of patients with heart failure with reduced ejection fraction heart (EFS40%) using Caaring® software.
The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with heart failure in the course of their disease will reduce the number of re-entries. For this, researchers will compare the assessments between the two groups.
This is a randomized study with two arms. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Prospective Control group: The data of these patients are collected prospectively for their routine medical visits for 12 weeks after their inclusion.
In addition, Control group patients must have clinical data from the 12 weeks after to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous monitoring devices.
Participants with heart failure will continue to receive conventional care and must have sufficient technological skills to use a smartphone.
Detailed description
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.
The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online telemonitoring group (G_CAARING) | Active comparator | Device: software Caaring (remote monitoring app)The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables. |
| Control Group (G_Control) | No intervention | –The data of these patients are collected prospectively from their routine medical visits for 12 weeks after inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older
- Patients diagnosed with heart failure with reduced ejection fraction (EFS40%)
- Patients discharged after an episode of acute heart failure and/or patients who are being followed up after being admitted for heart failure.
- Patients who extensively use a smartphone.
- lnformed Consent is obtained from the patient
Key exclusion criteria (8 listed)
- Patients with cognitive ar sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions ar the scales, as long as they do not have a legally authorized representative capable of participating in the study.
- Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
- Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
- Patients whose main diagnosis is a poorly controlled mental disorders ar other medical illness.
- Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
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 |
|---|---|---|
| software Caaring (remote monitoring app)Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/ questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G_CAARING) will receive educational and prevention recommendations relative to Heart Faillure. | Device | Online telemonitoring group (G_CAARING) |
Primary outcome
Number of re-entries in patients with heart failure
Time frame: Day 0, Week 12
Number of re-entries in patients with heart failure
7 secondary outcomes
Changes in Health-related quality of life (WHOQOL)
Time frame: Day 0, Week 12
Adherence treatment equal to or greater than 80%
Time frame: Day 0 and Weekly up to 12 weeks
Changas in the patient's MEDAS scale: Adherence to Mediterranean Diet
Time frame: Day 0, Week 12
Changes in the patient's Clinical Data
Time frame: Day O, every 3 days up to Week 12
Patient satisfaction with the software Caaring
Time frame: Week 12
Changes in the patient's in Liquid Consumption
Time frame: Day 0, Week 12
Adherence treatment equal to 100%
Time frame: Day 0 and Weekly up to 12 weeks
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 4 Jun 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing software Caaring (remote monitoring app) in people with Heart Failure With Reduced Ejection Fraction, run by Persei Vivarium at 2 sites in Spain.
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 8 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Contact Roberto Bravo (+34 915004013, roberto.bravo@perseivivarium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of re-entries in patients with heart failure (time frame: Day 0, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2025.