Clinical trial NCT02147340: External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators
Official title: External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators: the ESTIMATE-HF Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure
Keywords: Heart Failure patients
Remote Patient Management
External Sensors
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2014-05-26
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Heart failure patients implanted with cardiac Resynchronization therapy-defibrillator (CRT-D) or ICD (mono-VR- or dual chamber-DR) will receive an RPM system equipped with sensors for the measurement of weight and pressure for remote management.

Brief summary: This study has been designed to describe the use of Remote Patient Management (RPM) systems equipped with sensors for the measurement of weight and blood pressure in an Italian health care setting, verifying their efficacy and efficiency for the remote management of heart failure patients with implantable defibrillators. Moreover, their ease of use and acceptance by physician and patient will be assessed.

Detailed description: Based on positive outcomes from numerous randomized, controlled trials, the current European Society of Cardiology (ESC) guidelines and current American guidelines for the management of chronic heart failure include the implantable defibrillators as a standard of care in selected chronic heart failure patients .

Heart failure patients with implantable defibrillators often visit the hospital for unscheduled examinations, placing a great burden on healthcare providers. Device manufacturers offer a technology for remote defibrillator monitoring with the purpose of allowing physicians to remotely access patients' data and reducing unnecessary routine and interim visits. The Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study was a multicenter randomized trial designed to assess whether remote management can reduce emergency healthcare use in heart failure patients implanted with defibrillators endowed with specific diagnostic features compared with standard management consisting of scheduled in-office visits and patient response to audible alerts. Over 16 months, the rate of emergency department or urgent in-office visits for heart failure, arrhythmias, or device-related events decreased by 35% and total healthcare visits were 21% less frequent with remote monitoring.

The study confirmed that remote management of heart failure patients implanted with defibrillators allows timely notification of potentially critical situations. Moreover, it has the effect of shifting healthcare visits from the emergency department to the clinic and increasing the appropriateness of in-office visits, thereby reducing costs and the burden on the healthcare system.

Nonetheless, in the EVOLVO study these findings were obtained with defibrillators equipped with specific diagnostic and alerting capabilities, and thus they cannot be fully extended to different technologies. In particular, defibrillators were equipped with these alert capability for the detection of possible fluid accumulation and decompensation, and these alerts accounted for the majority of endpoints recorded during the study.

That alert was shown to be associated with a relatively high rate of false positive detections , and the Diagnostic Outcome Trial in Heart Failure (DOT-HF) recently showed an increased number of hospital admissions among patients with the audible alert enabled.

Alternative systems of RPM (Remote Patient Management) allow recording of the body weight and blood pressure for the management of heart failure. Continuous monitoring of these variables is a fundamental element of the programs of patient monitoring and patient education recommended by the guidelines for the treatment of heart failure.

Although the daily measure of body weight and pressure is present in most telemedicine programs described in the literature , , clinical evidence obtained specifically in the population of patients referred to the implantable defibrillator therapy is scarce. The large observational study ALTITUDE has suggested the possibility of a better prognosis of patients managed via RPM, in particular if provided with sensors for the measurement of weight and pressure.

Eligibility criteria: Inclusion Criteria:

* Patient with left ventricular systolic dysfunction, left ventricular ejection fraction ≤ 35%, as documented at the moment of device implant.
* Patient implanted with a Cardiac Resynchronization Therapy-Defibrillator (CRT-D) or implantable defibrillator (ICD) device.
* Patient must be able and willing to replace regularly-scheduled in-office routine follow-ups with remote follow-ups.
* Patient must be able to attend all required follow-up visits at the study center.

Exclusion Criteria:

* Patient is less than 18 years of age.
* Patient is unwilling or unable to sign an authorization to use and disclose health information or an Informed Consent.
* Patient life expectancy is less than 12 months.
* Patient is participating in another clinical study that may have an impact on the study endpoints.

Primary outcomes:
measure: Number of planned and unplanned admissions
timeFrame: 16 months
Secondary outcomes:
measure: The number of all cardiac or device related ED visits
timeFrame: 16 months
measure: The number of all unplanned cardiac or device related clinic/urgent visits
timeFrame: 16 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Policlinico San Matteo
Study officials:
affiliation: Policlinico San Matteo
name: Maurizio Eugenio Landolina
role: PRINCIPAL_INVESTIGATOR
References: