Heart Failure
Conditions
Keywords
Heart failure, Remote Monitoring, ICD, Follow-up
Brief summary
This is a clinical trial to evaluate the clinical benefit of remote monitoring in patients with heart failure having an ICD-CRT implanted. Study purpose The purpose of this study is to test the hypothesis that the monitoring of specific clinical parameters, obtained by remote controls of ICD-CRT could improve clinical course of patients with heart failure. Study design This is a prospective observational study, comparing clinical course of patients with heart failure having an ICD-CRT implanted, followed or not by remote monitoring. This study will include 870 subjects with ICD and CRT-D, and followed by a remote monitoring system (with or without weight and pressure external sensors) or followed by conventional ambulatory visits. Primary endpoints The primary endpoint of this study is to document no superiority of unplanned hospital access for cardiac reasons (included access to the emergency units ) or death for cardiovascular causes in remote monitoring group (with or without weight and pressure external sensors) compared to conventional follow-up (usual care group).
Detailed description
Aim of the study The purpose of this study is to evaluate the clinical benefit of a dedicated remote monitoring system (RPM) in the management of patients with heart failure and implanted with ICDs and CRT-D. The clinical benefit will be assessed by: * Increased cardiovascular events (death, myocardial infarction, hospitalization). * Events arrhythmia: atrial fibrillation, sustained and nonsustained ventricular tachycardia or ventricular fibrillation. * Autonomic profile, echocardiographic parameters, 6-minute walk test, quality of life questionnaire. The primary endpoint of this study is to estimate the incidence (and its accuracy) of the first event of unplanned hospitalizations for cardiac reasons or death from cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care).
Interventions
None listed
Sponsors
Effect Group, Italy
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects \>18 years * patients implanted or eligible for implant with ICD-CRT-D, accordingly with guidelines of the centers, for heart failure treatment and/or primary prevention of sudden death
Exclusion criteria
* Presence of clinically overt heart failure. * Myocardial infarction within 2 months before enrolment. * Significant concurrent illness or condition severely limiting life expectancy. * Any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period. * History of drug or alcohol abuse within the last 2 years. * Inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| unplanned hospitalizations or death | 1 year | unplanned hospitalization or for cardiac reasons or death for cardiovascular causes in the group monitored using RPM (with or without external sensors) and in the group management via conventional follow-up (Usual Care). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All reasons hospitalizations | 1 year | — |
| Hospitalization for cardiac causes | 1 year | — |
| Myocardial infarction | 1 year | Incidence of myocardial infarction |
| Ventricular tachycardia or fibrillation | 1 year | Incidence of ventricular tachycardia or fibrillation |
| Heart transplantation | 1 year | heart transplantation occurence |
| Cost for National Health System (NHS) | 1 year | Estimate the total cost for the NHS for the management of heart failure patients implanted with ICD-CRT, monitored or not with a remote monitoring system. |
| Clinical benefit | 1 year | Evaluate the clinical benefit by means of 6-minute walking test, use of medications and changes of echocardiographic parameters, between the patients followed by conventional visits and patients followed by remote controls (with or without external sensors). |
| Atrial fibrillation | 1 year | Incidence of atrial fibrillation episodes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Autonomic activity | 1 year | Indexes of autonomic activity such as th mean of standard deviations of RR intervals calculated on 5 minutes intervals (SDANN), activity log and footprint, will be compared in patients followed by conventional visits of by remote controls. |
Countries
Italy
Outcome results
None listed