Congestive Heart FailureESTIMATE-HFNCT02147340
External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators
An observational study of Congestive Heart Failure, run by Maurizio Eugenio Landolina at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 186 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Maurizio Eugenio Landolina contact
Italy1 site
Policlinico San Matteo
Pavia, Pavia, 27100
Maurizio Eugenio Landolina
About this study
Official title: External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators: the ESTIMATE-HF Study
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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Keywords
- Heart Failure patients, Remote Patient Management, External Sensors
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients with ICD | Heart failure patients with ICD and RPM system equipped with sensors for the measurement of weight and pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of planned and unplanned admissions
All planned and unplanned hospital and Emergency Department (ED) admissions (not involving an overnight stay) All planned and unplanned hospitalizations (involving an overnight stay or resulting in death)
Measured: 16 months
Secondary outcomes (2)
The number of all cardiac or device related ED visits
Measured: 16 months
The number of all unplanned cardiac or device related clinic/urgent visits
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maurizio Eugenio Landolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maurizio Eugenio Landolina, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Maurizio Eugenio Landolina, Principal investigator, Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147340
- Sponsor's protocol ID
- 20130004180 del 24/09/2013
- Acronym
- ESTIMATE-HF
- Status last verified
- May 2014
- First submitted
- 22 May 2014
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable Defibrillators: the ESTIMATE-HF Study
- ClinicalTrials.gov ID
- NCT02147340
- Acronym / sponsor ID
- ESTIMATE-HF / 20130004180 del 24/09/2013
- Conditions
- Congestive Heart Failure
- Keywords
- Heart Failure patients, Remote Patient Management, External Sensors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Maurizio Eugenio LandolinaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients with ICD | – | –Heart failure patients with ICD and RPM system equipped with sensors for the measurement of weight and pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of planned and unplanned admissions
Time frame: 16 months
All planned and unplanned hospital and Emergency Department (ED) admissions (not involving an overnight stay) All planned and unplanned hospitalizations (involving an overnight stay or resulting in death)
2 secondary outcomes
The number of all cardiac or device related ED visits
Time frame: 16 months
The number of all unplanned cardiac or device related clinic/urgent visits
Time frame: 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Eugenio Landolina contact
Maurizio Eugenio Landolina principal investigator
Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Maurizio Eugenio Landolina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurizio Eugenio Landolina (clinical-estimate@isis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of planned and unplanned admissions (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2014.