Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Remote monitoring with Caaring for people with reduced ejection fraction heart failure

Official title: Determination of the Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction Using Caaring® Software

Run by Persei Vivarium · NCT06920160 · Data updated 2026-11-12

Test whether using the Caaring smartphone app for remote monitoring helps people with reduced ejection fraction heart failure avoid hospital readmission over 12 weeks.

More Heart Failure With Reduced Ejection Fraction trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment196 (estimated)
SponsorPersei Vivarium
Academic / other
Locations2 sites (Ferrol, A Coruña and 1 other locations)
StatusRecruiting
StartedApril 15, 2025
Main results expectedJuly 2025
Study endsAugust 2025
Registry record updatedJune 4, 2025
Trial IDNCT06920160 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with heart failure and reduced ejection fraction (EF ≤40%) recently discharged after an acute heart failure episode or in follow-up who routinely use a smartphone and can give informed consent.

Probably not a fit

Patients who cannot use a smartphone, have cognitive or significant sensory impairments without a legal representative, or who cannot complete follow-up due to relocation are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter, non-inferiority trial compares remote telemonitoring via the Caaring® software to routine prospective follow-up in patients with heart failure and reduced ejection fraction. Participants are randomly assigned to the Caaring telemonitoring arm or a prospective control arm, with clinical data collected for 12 weeks after inclusion. The Caaring platform supports patient self-management and captures remote symptom and device-reported data through the patient’s smartphone to trigger clinical alerts. The primary comparison focuses on rates of rehospitalization or clinical re-entries during the follow-up period.

Why it matters

Potential benefit: If successful, the app could reduce hospital readmissions and improve self-management for people with reduced ejection fraction heart failure.

How similar studies have gone: Previous telemonitoring and remote-monitoring trials in heart failure have shown mixed but sometimes positive results on readmissions and self-care, while Caaring® itself appears novel and not yet widely validated.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Hospital Universitario de Son Llatzer
    Palma de Mallorca, Balearic Islands, Spain
    Recruiting
  • Complejo Hospitalario Universitario de Ferrol
    Ferrol, A Coruña, Spain
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.