NCT06920160Recruiting
Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 15 Apr 2025
- Primary completion date
- Jul 2025
- Lead sponsor
- Persei Vivarium
- Diseases
- Heart failure
- NCT number
- NCT06920160
What you commit to
- Study type: Interventional
- Planned participants: 196
- From 15 Apr 2025 to the primary completion date, Jul 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Other
- 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.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario Universitario de Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Not yet recruiting |
| Hospital Universitario de Son Llatzer Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.