Clinical Benefits in Optimized Remote HF Patient Management (COR-HF)
This study is currently recruiting participants.
Verified November 2011 by St. Jude Medical
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01482598
First received: November 28, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure Treated |
Device: Remote Care Follow up |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | COR HF - Clinical Benefits in Optimized Remote HF Patient Management |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Primary Outcome Measures:
- Combined Endpoint on patient clinical outcome [ Time Frame: 12 months follow up ] [ Designated as safety issue: Yes ]
Combined Endpoint:
- proportion of patients with HF hospitalization or emergency unit admission with intravenous diuretics, AT/AF episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
- proportion of patients with inappropriate ICD therapies delivered at 12 months
Secondary Outcome Measures:
- Efficacy and safety of CRT in remote care pts [ Time Frame: 12 and 24 months follow up ] [ Designated as safety issue: Yes ]
Proportion of patients with additional unscheduled clinic fups at 24 months
- % biventricular pacing at 12 and 24 months
- LVESV reduction >15% at 12 months
- Time to first clinical event
- Time from onset of the event to the clinical intervention
- Mortality at 24 months
| Estimated Enrollment: | 438 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Optimal Remote Care
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.
|
Device: Remote Care Follow up
Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete trasmission with all device data is performed
Other Name: Home monitoring, Remote monitoring, Merlin.net
|
|
No Intervention: Optimal Standard Care
Patient standard in clinic visits are performed every 6 months.
|
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, AT/AF episodes or cardiovascular/cerebrovascular episodes requiring hospitalization at 12 months
- Proportion of patients with inappropriate ICD therapies delivered at 12 months comparing optimized remote patient management to optimized standard patient management
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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 LV lead
- Patients with mechanical valvular prosthesis
- Patients with life expectancy < 12 months
- Patients actively considered for cardiac transplant
- Patients < 18 years old
- Pregnant women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482598
Contacts
| Contact: Paolo Silvestri | +390396074750 | psilvestri@sjm.com |
| Contact: Tiziana Guidotto Paolo Amato | +390396074761 | tguidotto@sjm.com/pamato@sjm.com |
Locations
| Italy | |
| Osp. S.Raffaele Giglio | Not yet recruiting |
| Cefalù, Palermo, Italy | |
| Contact: Gabriele Giannola, MD | |
| Principal Investigator: Gabriele Giannola, MD | |
| Presidio Ospedaliero Riunito di Ciriè | Not yet recruiting |
| Ciriè, Torino, Italy | |
| Contact: Gaetano Senatore, MD | |
| Principal Investigator: Gaetano Senatore, MD | |
| Casa di Cura Pederzoli | Not yet recruiting |
| Peschiera, VR, Italy, 37019 | |
| Contact: Alfredo Vicentini, MD | |
| Principal Investigator: Alfredo Vicentini, MD | |
| Università Cattolica Sacro Cuore | Not yet recruiting |
| Campobasso, Italy | |
| Contact: Francesco Alessandrini, prof. | |
| Principal Investigator: Francesco Alessandrini, Prof | |
| Ospedale Ferrarotto Vittorio Emanuele | Not yet recruiting |
| Catania, Italy | |
| Contact: Valeria Calvi, prof. | |
| Principal Investigator: Valeria Calvi, prof. | |
| Ospedale Guglielmo da Saliceto | Not yet recruiting |
| Piacenza, Italy | |
| Contact: Giovanni Quinto Villani, MD | |
| Principal Investigator: Giovanni Quinto Villani, MD | |
| Policlinico Tor Vergata | Recruiting |
| Roma, Italy | |
| Contact: Luca MD Santini, MD | |
| Principal Investigator: Francesco Romeo, Prof | |
Sponsors and Collaborators
St. Jude Medical
Investigators
| Study Chair: | Luigi Padeletti, Prof. | Clinica Medica, Azienda Ospedaliero Universitaria Careggi, Firenze |
| Principal Investigator: | Maria Grazia Bongiorni, MD | Ospedale S.Chiara-Cisanello, Pisa |
| Principal Investigator: | Gerardo Ansalone, MD | Ospedale Vannini, Roma |
| Principal Investigator: | Gianluca Botto, MD | Osp.S.Anna, Como |
| Principal Investigator: | Antonio Curnis, MD | Spedali Civili, Brescia |
| Principal Investigator: | Stefano Favale, Prof. | Policlinico Consorziale Bari |
| Principal Investigator: | Edoardo Gronda, MD | Multimedica IRCCS Milano |
| Principal Investigator: | Roberto Verlato, MD | Ospedale Cosma, Camposampiero |
| Principal Investigator: | Alessandro Proclemer | Ospedale Misericordia Udine |
| Principal Investigator: | Luca Santini, MD | Policlinico Tor Vergata, Roma |
More Information
Publications:
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT01482598 History of Changes |
| Other Study ID Numbers: | CR‐11‐017‐IT‐HF |
| Study First Received: | November 28, 2011 |
| Last Updated: | November 28, 2011 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by St. Jude Medical:
|
Heart Failure Cardiac Resynchronization Therapy Remote Care Disease Management |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013