NCT06920160 Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
| NCT ID | NCT06920160 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Persei Vivarium |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 196 participants in total. It began in 2025-04-15 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06920160 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06920160 currently recruiting?
Yes, NCT06920160 is actively recruiting participants. Contact the research team at roberto.bravo@perseivivarium.com for enrollment information.
Where is the NCT06920160 trial being conducted?
This trial is being conducted at Ferrol, Spain, Palma de Mallorca, Spain.
Who is sponsoring the NCT06920160 clinical trial?
NCT06920160 is sponsored by Persei Vivarium. The trial plans to enroll 196 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.