Congestive Heart Failure TreatedCOR-HFNCT01482598
Clinical Benefits in Optimized Remote HF Patient Management
A study testing Remote Care Follow up in people with Congestive Heart Failure Treated, run by Abbott Medical Devices at 18 sites in Italy.
Trial summary
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congestive Heart Failure Treated
- What is being tested?
- Remote Care Follow up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 18 sitesItaly
- Study dates
- Oct 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
- 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months
- Left Bundle Branch Block (LBBB)
- Patients must be able to provide written informed consent
- Patients are mentally capable to participate in the Investigation (based on physician's discretion)
Who cannot join
- Patients already implanted with CRT or CRT-D device to be replaced
- Patients in long-standing persistent or permanent AT/AF
- Patients in dialysis treatment at the time of enrollment
- Patients in parenteral inotropic therapy at the time of enrollment
- Patients with epicardial Left Ventricular (LV) lead
- Patients with mechanical valvular prosthesis
Show all 10Show fewer
- Patients with life expectancy < 12 months
- Patients actively considered for cardiac transplant
- Patients < 18 years old
- Pregnant women
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Italy18 sites
Azienda Ospedaliero Universitaria "Ospedali Riuniti"
Ancona
Policlinico Consorziale
Bari
Spedali Civili
Brescia
Ospedale Pietro Cosma
Camposampiero, Padova
Ospedale Ferrarotto Vittorio Emanuele
Catania
Osp. S.Raffaele Giglio
Cefalù, Palermo
Presidio Ospedaliero Riunito di Ciriè
Cirié, Torino
Ospedale S. Anna
Como
Presidio Ospedaliero di Conegliano
Conegliano, Treviso
Azienda Ospedaliero Universitaria Careggi
Florence
Casa di Cura "Montevergine"
Mercogliano, Avellino
Azienda Ospedaliera dei Colli - Ospedale Monaldi
Naples
Casa di Cura Pederzoli
Peschiera del Garda, Verona
Ospedale Guglielmo da Saliceto
Piacenza
Ospedale S. Chiara - Cisanello
Pisa
Ospedale Vannini
Roma
Policlinico Tor Vergata
Roma
Ospedale di Belcolle
Viterbo
About this study
Official title: COR HF - Clinical Benefits in Optimized Remote HF Patient Management
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT-D) device reprogramming.
Read the detailed description
The outcome measure of the study is a combined endpoint of:
- Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
- Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management
- Conditions
- Congestive Heart Failure Treated
- Being tested
- Remote Care Follow up
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, Remote Care, Disease Management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Care Follow upDevice
Also called Home monitoring, Remote monitoring, Merlin.net
Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
| Study group | Role | What they receive |
|---|---|---|
| Optimal Remote Care | Active comparator | Patient follow up is performed through remote care, remote alerts on CRT-D device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant. Receives: Device: Remote Care Follow up |
| Optimal Standard Care | No intervention | Patient standard in clinic visits are performed every 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Endpoint on Patient Clinical Outcome
Combined Endpoint:
- proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
- proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months
Measured: 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart Failure TreatedStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luigi Padeletti, Prof., Study chair, Azienda Ospedaliero-Universitaria CareggiMaria Grazia Bongiorni, MD, Principal investigator, Ospedale S.Chiara-Cisanello, PisaGerardo Ansalone, MD, Principal investigator, Ospedale Vannini, RomaGianluca Botto, MD, Principal investigator, Ospedale S. Anna, ComoAntonio Curnis, MD, Principal investigator, Spedali Civili, BresciaStefano Favale, Prof., Principal investigator, Policlinico Consorziale, BariEdoardo Gronda, MD, Principal investigator, Multimedica IRCCS, MilanoRoberto Verlato, MD, Principal investigator, Ospedale Pietro Cosma, Camposampiero (PD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482598
- Sponsor's protocol ID
- CR-11-017-IT-HF
- Acronym
- COR-HF
- Status last verified
- Oct 2020
- First submitted
- 28 Nov 2011
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Santini M, Ricci RP, Lunati M, Landolina M, Perego GB, Marzegalli M, Schirru M, Belvito C, Brambilla R, Guenzati G, Gilardi S, Valsecchi S. Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes. J Interv Card Electrophysiol. 2009 Jan;24(1):53-61. doi: 10.1007/s10840-008-9321-3. Epub 2008 Oct 31.
PubMed 18975066Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x.
PubMed 18811805Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, McRae S, Toledo GB, Sarkar S, Hettrick DA; FAST Study Investigators. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). Congest Heart Fail. 2011 Mar-Apr;17(2):51-5. doi: 10.1111/j.1751-7133.2011.00220.x. Epub 2011 Mar 21.
PubMed 21449992Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034.
PubMed 20569704Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
PubMed 21080835
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COR HF - Clinical Benefits in Optimized Remote HF Patient Management
- ClinicalTrials.gov ID
- NCT01482598
- Acronym / sponsor ID
- COR-HF / CR-11-017-IT-HF
- Conditions
- Congestive Heart Failure Treated
- Keywords
- Heart Failure, Cardiac Resynchronization Therapy, Remote Care, Disease Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Study Purpose is to demonstrate the superiority of optimized remote patient management compared to optimized standard care in the management and prognosis of heart failure, in the prevention of recurrent atrial tachycardia or atrial fibrillation episodes and in the reduction of inappropriate shock therapies. The remote care allows early intervention in terms of drug therapy adjustment and cardiac resynchronization therapy (CRT-D) device reprogramming.
Detailed description
The outcome measure of the study is a combined endpoint of:
- Proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
- Proportion of patients with inappropriate Implantable Cardioverter-Defibrillator (ICD) therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal Remote Care | Active comparator | Device: Remote Care Follow upPatient follow up is performed through remote care, remote alerts on CRT-D device data are transmitted daily to the hospital, remote follow up is scheduled every 6 months, hospital in clinic follow up is scheduled at 12 months after implant. |
| Optimal Standard Care | No intervention | –Patient standard in clinic visits are performed every 6 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Heart failure patients already implanted with CRT-D devices (from 4 to 8 weeks), according to current guidelines1
- 1 hospitalization or access to emergency unit due to heart failure (including treatment with diuretic and/or cardioactive intravenous therapy) within the last 12 months
- Left Bundle Branch Block (LBBB)
- Patients must be able to provide written informed consent
- Patients are mentally capable to participate in the Investigation (based on physician's discretion)
Key exclusion criteria (10 listed)
- Patients already implanted with CRT or CRT-D device to be replaced
- Patients in long-standing persistent or permanent AT/AF
- Patients in dialysis treatment at the time of enrollment
- Patients in parenteral inotropic therapy at the time of enrollment
- Patients with epicardial Left Ventricular (LV) lead
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Care Follow upAlso: Home monitoring, Remote monitoring, Merlin.netPatient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed | Device | Optimal Remote Care |
Primary outcome
Combined Endpoint on Patient Clinical Outcome
Time frame: 12 months follow up
Combined Endpoint: * proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months * proportion of patients with inappropriate Implantable Cardiac Defibrillator (ICD) therapies delivered at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18975066Santini M, Ricci RP, Lunati M, Landolina M, Perego GB, Marzegalli M, Schirru M, Belvito C, Brambilla R, Guenzati G, Gilardi S, Valsecchi S. Remote monitoring of patients with biventricular defibrillators through the CareLink system improves clinical management of arrhythmias and heart failure episodes. J Interv Card Electrophysiol. 2009 Jan;24(1):53-61. doi: 10.1007/s10840-008-9321-3. Epub 2008 Oct 31.
- Background: PubMed 18811805Marzegalli M, Lunati M, Landolina M, Perego GB, Ricci RP, Guenzati G, Schirru M, Belvito C, Brambilla R, Masella C, Di Stasi F, Valsecchi S, Santini M. Remote monitoring of CRT-ICD: the multicenter Italian CareLink evaluation--ease of use, acceptance, and organizational implications. Pacing Clin Electrophysiol. 2008 Oct;31(10):1259-64. doi: 10.1111/j.1540-8159.2008.01175.x.
- Background: PubMed 21449992Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, McRae S, Toledo GB, Sarkar S, Hettrick DA; FAST Study Investigators. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). Congest Heart Fail. 2011 Mar-Apr;17(2):51-5. doi: 10.1111/j.1751-7133.2011.00220.x. Epub 2011 Mar 21.
- Background: PubMed 20569704Abraham WT, Gras D, Yu CM, Guzzo L, Gupta MS; FREEDOM Steering Committee. Rationale and design of a randomized clinical trial to assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy: the Frequent Optimization Study Using the QuickOpt Method (FREEDOM) trial. Am Heart J. 2010 Jun;159(6):944-948.e1. doi: 10.1016/j.ahj.2010.02.034.
- Background: PubMed 21080835Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
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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.
Luigi Padeletti, Prof. study chair
Azienda Ospedaliero-Universitaria Careggi
Maria Grazia Bongiorni, MD principal investigator
Ospedale S.Chiara-Cisanello, Pisa
Gerardo Ansalone, MD principal investigator
Ospedale Vannini, Roma
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Care Follow up in people with Congestive Heart Failure Treated, run by Abbott Medical Devices at 18 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 5 inclusion and 10 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Combined Endpoint on Patient Clinical Outcome (time frame: 12 months follow up). 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 NCT01482598, which also lists 5 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 16 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.