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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
HeartLogic or TriageHF Algorithms for implantable devices
Other interventionActivation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Interventional groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Composite Outcome
All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area.
Time frame
2 yearsSecondary outcomes
1
All-cause mortality
All-cause mortality
Time frame
2 years2
Hospital admission for Heart Failure
Patient admission to the hospital with symptoms or signs of congestive heart failure, needing intravenous drugs for symptom relief, ultrafiltration therapy, or other parenteral therapy
Time frame
2 years3
Worsening Heart failure
Unscheduled hospital visit (to the emergency department or unscheduled consultation) due to signs or symptoms of heart failure, where intravenous diuretics were administered or ambulatory diuretic dosage was increased.
Time frame
2 eras4
Ventricular Arrhythmias
Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection
Time frame
2 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: