Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-15
Brief Title:
Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial
Sponsor:
Centro Hospitalar e Universitário de Coimbra EPE
Organization:
Centro Hospitalar e Universitário de Coimbra EPE
Study Overview
Official Title:
Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMOTI-HF
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
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 algorithms output with established biomarkers specifically NT-proBNP in the context of heart failure progression and severity if possible
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 algorithms output with established biomarkers specifically NT-proBNP in the context of heart failure progression and severity if possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None