Congestive Heart Failure Treated Clinical Trial
— COR-HFOfficial title:
COR HF - Clinical Benefits in Optimized Remote HF Patient Management
| Verified date | October 2020 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 144 |
| Est. completion date | September 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 Left Ventricular (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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Ospedaliero Universitaria "Ospedali Riuniti" | Ancona | |
| Italy | Policlinico Consorziale | Bari | |
| Italy | Spedali Civili | Brescia | |
| Italy | Ospedale Pietro Cosma | Camposampiero | Padova |
| Italy | Ospedale Ferrarotto Vittorio Emanuele | Catania | |
| Italy | Osp. S.Raffaele Giglio | Cefalù | Palermo |
| Italy | Presidio Ospedaliero Riunito di Ciriè | Ciriè | Torino |
| Italy | Ospedale S. Anna | Como | |
| Italy | Presidio Ospedaliero di Conegliano | Conegliano | Treviso |
| Italy | Azienda Ospedaliero Universitaria Careggi | Firenze | |
| Italy | Casa di Cura "Montevergine" | Mercogliano | Avellino |
| Italy | Azienda Ospedaliera dei Colli - Ospedale Monaldi | Napoli | |
| Italy | Casa di Cura Pederzoli | Peschiera del Garda | Verona |
| Italy | Ospedale Guglielmo da Saliceto | Piacenza | |
| Italy | Ospedale S. Chiara - Cisanello | Pisa | |
| Italy | Ospedale Vannini | Roma | |
| Italy | Policlinico Tor Vergata | Roma | |
| Italy | Ospedale di Belcolle | Viterbo |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
Italy,
Abraham 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. — View Citation
Abraham 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. Review. — View Citation
Chaudhry 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. Erratum in: N Engl J Med. 2011 Feb 3;364(5):490. N Engl J Med. 2013 Nov 7;369(19):1869. — View Citation
Marzegalli 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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
12 months follow up |