Status:
RECRUITING
Efficacy of Remote Monitoring of Patients With Heart Failure and Reduced Ejection Fraction by Using Caaring® Software
Lead Sponsor:
Persei Vivarium
Collaborating Sponsors:
Effice Servicios Para la Investigacion S.L.
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
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 Ca...
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 hospita...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06920160
Start Date
April 15 2025
End Date
August 1 2025
Last Update
June 4 2025
Active Locations (2)
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1
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, Spain, 15405
2
Hospital Universitario de Son Llatzer
Palma de Mallorca, Balearic Islands, Spain, 07198