Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUnidade Local de Saúde de Coimbra, EPE
About this trial
Heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life.
The REMOTI-HF is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the HeartLogic and TriageHF algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. The primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure.
Moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. Additionally, the research will explore the relationship between the absolute values provided by the algorithms and NT-proBNP values.
Eligibility criteria
Qualifiers
Possession of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device that is compatible with the HeartLogic or TriageHF algorithms.
Left ventricular ejection fraction at the time of device implantation must be equal to or less than 35%.
Disqualifiers
Younger than 18 years old or older than 85 years old.
Unable to be contacted when out of the hospital.
Presence of severe cognitive impairment.
Currently on the heart transplant waiting list
Trial design
Treatments tested in this trial
- HeartLogic or TriageHF Algorithms for implantable devices
Treatment groups
270 Participants
are divided into 2 treatment groupsLocations
This trial has no locations
Sponsors and collaborators
Unidade Local de Saúde de Coimbra, EPE
Lead sponsor
Source ClinicalTrials.gov