Arrythmia, Heart Failure
Conditions
Keywords
Heart Failure, Remote Monitoring, ICD, CRT
Brief summary
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.
Detailed description
Patients will be randomized into two arms: one with the activation of the algorithm and the other with no active algorithm. The algorithm is programmed to alert our team upon detecting a patient at risk of worsening heart failure. When an alarm is triggered, the patient will receive a telephone call from the investigation team. Subsequently, the patient may be scheduled for a hospital visit, or ambulatory medication adjustments can be made. For patients in whom the algorithm is deactivated, no such alarm mechanism will be in place. Patients in both arms will undergo comparison based on relevant heart failure events, defined as follows: * All-Cause Mortality * Hospital Admission for Heart Failure * Hospital Visit for Worsening Heart Failure * Ventricular Arrhythmias * Atrial Arrhythmias Additionally, the study will explore the association between physical activity measured by the devices and these specified events. In addition to evaluating patient outcomes, a correlation analysis will be conducted to examine the relationship between the absolute value provided by the algorithm and absolute NT-proBNP values. This analysis aims to assess the concordance and potential predictive value of the algorithm's output with established biomarkers, specifically NT-proBNP, in the context of heart failure progression and severity (if possible).
Interventions
OTHERHeartLogic or TriageHF Algorithms for implantable devices
Activation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design
Sponsors
Unidade Local de Saúde de Coimbra, EPE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients will not know whether the algorithms was activated or not at the beginning of the study. However, if a contact with the patient is made due to the algorithm, the patient will then understand they are not on the control group. The person responsible for contacts will also know if an individual patient is on the control or intervention group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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%.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Composite Outcome | 2 years | All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 2 years | All-cause mortality |
| Hospital admission for Heart Failure | 2 years | 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 |
| Worsening Heart failure | 2 eras | 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. |
| Ventricular Arrhythmias | 2 years | Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection |
| Atrial Arrhytmias | 2 years | Occurrence of any atrial arrhythmia prompting medical evaluation. |
Contacts
Primary ContactGonçalo Batista, MD
Outcome results
None listed