Heart FailureEFFECTNCT01723865
Clinical Efficacy of Remote Monitoring in the Management of Heart Failure
An observational study of Heart Failure, run by Effect Group, Italy at 16 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 988 participants
- Where
- 16 sitesItaly
- Study dates
- May 2011to Mar 2014
- 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: Patients of both gender implanted or eligible for implant with ICD-CRT-D, for heart failure treatment and/or primary prevention of sudden death, followed or not by a remote monitoring system.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Italy16 sites
Ospedali riuniti di Ancona
Ancona, 60126
Azienda Ospededaliero Universitaria Policlinico
Bari, 70125
Ospedale di Venere
Bari, 70131
Ospedale S.Spirito
Casale Monferrato, 15033
Ferrari Hospital
Casarano, 73042
Presidio Ospedaliero Ferrari
Castrovillari, 87012
Policlinico V,Emanuele - Cardiologia Ferrarotto
Catania, 95124
Fondazione Istituto San Raffaele G.Giglio
Cefalù, 90015
Dep. of Cardiology, Civic Hospital
Cirié, 10073
Vito Fazzi Hospital
Lecce, 73100
Civic Hospital
Moncalieri, 10024
Ospedale dei Colli - Monaldi
Naples, 80100
Clinica Mediterranea
Naples, 80122
Ospedale dei Colli, Monaldi
Naples, 80131
Dept. Cardiology, S. Cuore Hospital
Negrar, 37024
Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari-Università di Padova
Padova, 35128
About this study
Official title: Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&CRT-D.
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.
Read more
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).
Read the 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).
- Conditions
- Heart Failure
- Keywords
- Heart failure, Remote Monitoring, ICD, Follow-up
- 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 |
|---|---|---|
| Conventional | Patients with heart failure having an ICD-CRT implanted, followed by conventional visits. | |
| Remote Monitoring | Patients with heart failure having an ICD-CRT implanted, followed by remote monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
unplanned hospitalizations or death
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).
Measured: 1 year
Secondary outcomes (8)
All reasons hospitalizations
Measured: 1 year
Hospitalization for cardiac causes
Measured: 1 year
Myocardial infarction
Incidence of myocardial infarction
Measured: 1 year
Ventricular tachycardia or fibrillation
Incidence of ventricular tachycardia or fibrillation
Measured: 1 year
Atrial fibrillation
Incidence of atrial fibrillation episodes.
Measured: 1 year
Heart transplantation
heart transplantation occurence
Measured: 1 year
Cost for National Health System (NHS)
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.
Measured: 1 year
Clinical benefit
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startMay 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effect Group, Italy
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gianfranco Buja, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723865
- Sponsor's protocol ID
- Effect
- Acronym
- EFFECT
- Status last verified
- Aug 2014
- First submitted
- 23 Oct 2012
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Capucci A, De Simone A, Luzi M, Calvi V, Stabile G, D'Onofrio A, Maffei S, Leoni L, Morani G, Sangiuolo R, Amellone C, Checchinato C, Ammendola E, Buja G. Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study. Europace. 2017 Sep 1;19(9):1493-1499. doi: 10.1093/europace/eux017.
PubMed 28407139De Simone A, Leoni L, Luzi M, Amellone C, Stabile G, La Rocca V, Capucci A, D'onofrio A, Ammendola E, Accardi F, Valsecchi S, Buja G. Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study. Europace. 2015 Aug;17(8):1267-75. doi: 10.1093/europace/euu318. Epub 2015 Apr 4.
PubMed 25842271
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of a Specifically Dedicated Remote Monitoring System in the Management of Patients With Heart Failure and ICD&CRT-D.
- ClinicalTrials.gov ID
- NCT01723865
- Acronym / sponsor ID
- EFFECT / Effect
- Conditions
- Heart Failure
- Keywords
- Heart failure, Remote Monitoring, ICD, Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 988 participants (actual)
- Lead sponsor
- Effect Group, ItalyResearch network
- Study start
- May 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Nov 2012 (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 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | – | –Patients with heart failure having an ICD-CRT implanted, followed by conventional visits. |
| Remote Monitoring | – | –Patients with heart failure having an ICD-CRT implanted, followed by remote monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both gender implanted or eligible for implant with ICD-CRT-D, for heart failure treatment and/or primary prevention of sudden death, followed or not by a remote monitoring system.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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
unplanned hospitalizations or death
Time frame: 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).
8 secondary outcomes
All reasons hospitalizations
Time frame: 1 year
Hospitalization for cardiac causes
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Ventricular tachycardia or fibrillation
Time frame: 1 year
Atrial fibrillation
Time frame: 1 year
Heart transplantation
Time frame: 1 year
Cost for National Health System (NHS)
Time frame: 1 year
Clinical benefit
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Derived from this study: PubMed 28407139Capucci A, De Simone A, Luzi M, Calvi V, Stabile G, D'Onofrio A, Maffei S, Leoni L, Morani G, Sangiuolo R, Amellone C, Checchinato C, Ammendola E, Buja G. Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study. Europace. 2017 Sep 1;19(9):1493-1499. doi: 10.1093/europace/eux017.
- Derived from this study: PubMed 25842271De Simone A, Leoni L, Luzi M, Amellone C, Stabile G, La Rocca V, Capucci A, D'onofrio A, Ammendola E, Accardi F, Valsecchi S, Buja G. Remote monitoring improves outcome after ICD implantation: the clinical efficacy in the management of heart failure (EFFECT) study. Europace. 2015 Aug;17(8):1267-75. doi: 10.1093/europace/euu318. Epub 2015 Apr 4.
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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.
Gianfranco Buja, MD principal investigator
University of Padova
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Effect Group, Italy at 16 sites 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
unplanned hospitalizations or death (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723865, which also lists 2 linked publications.
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 5 Aug 2014.