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The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial.The purpose of the study is to assess a short term and a long term period, incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation.
The CARRYING ON for heart failure (HF) study is a national, prospective, post market interventional, multi-center, open-label, pilot trial designed in two phases.
The purpose of the study is to assess a short term (6 months follow-up - Phase 1) and a long term period (24 months follow-up - Phase 2), incidence of pre-specified clinical and arrhythmic events in patients with a low ejection fraction (EF) that are hospitalized for acute cardiac decompensation. A previously implanted Reveal® XT device will be used to collect heart rhythm information.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote patient's management | Behavioral | scheduled remote CareLink data transmission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: incidence of pre-specified clinical and arrhythmic events | In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include:
| implant to 6 months post-implant |
| Phase II: incidence of pre-specified clinical and arrhythmic events | In patients with low ejection fraction that are hospitalized for acute cardiac decompensation, the pre-specified events include:
| implant to 24 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT | Document the incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal XT. The pre-specified secondary clinical and arrhythmic events are:
|
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Inclusion Criteria:
Exclusion Criteria:
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Hf patients without indication to permanent device implant (PM/ICD/CRT)
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| Name | Affiliation | Role |
|---|---|---|
| CARRYING ON Study Trial Leader | Medtronic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. SS. Antonio e Biagio e Cesare Arrigo di Alessandria | Alessandria | Alessandria | 15100 | Italy | ||
| A.O. Ospedale S. Anna di Como |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14668697 | Background | Fonarow GC; ADHERE Scientific Advisory Committee. The Acute Decompensated Heart Failure National Registry (ADHERE): opportunities to improve care of patients hospitalized with acute decompensated heart failure. Rev Cardiovasc Med. 2003;4 Suppl 7:S21-30. | |
| 15681577 | Background | Nieminen MS, Bohm M, Cowie MR, Drexler H, Filippatos GS, Jondeau G, Hasin Y, Lopez-Sendon J, Mebazaa A, Metra M, Rhodes A, Swedberg K, Priori SG, Garcia MA, Blanc JJ, Budaj A, Cowie MR, Dean V, Deckers J, Burgos EF, Lekakis J, Lindahl B, Mazzotta G, Morais J, Oto A, Smiseth OA, Garcia MA, Dickstein K, Albuquerque A, Conthe P, Crespo-Leiro M, Ferrari R, Follath F, Gavazzi A, Janssens U, Komajda M, Morais J, Moreno R, Singer M, Singh S, Tendera M, Thygesen K; ESC Committe for Practice Guideline (CPG). Executive summary of the guidelines on the diagnosis and treatment of acute heart failure: the Task Force on Acute Heart Failure of the European Society of Cardiology. Eur Heart J. 2005 Feb;26(4):384-416. doi: 10.1093/eurheartj/ehi044. Epub 2005 Jan 28. No abstract available. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| implant to 6 months post-implant |
| Phase II: incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal® XT | Document the incidence of the pre-specified secondary clinical and arrhythmic events in patients implanted with the Reveal XT. The pre-specified secondary clinical and arrhythmic events are:
| implant to 24 months post-implant |
| Como |
| Como |
| 22100 |
| Italy |
| Policlinico di Monza | Monza | Monza | 20052 | Italy |
| Clinica San Gaudenzio | Novara | Novara | 28100 | Italy |
| 14564335 | Background | Di Lenarda A, Scherillo M, Maggioni AP, Acquarone N, Ambrosio GB, Annicchiarico M, Bellis P, Bellotti P, De Maria R, Lavecchia R, Lucci D, Mathieu G, Opasich C, Porcu M, Tavazzi L, Cafiero M; TEMISTOCLE Investigators. Current presentation and management of heart failure in cardiology and internal medicine hospital units: a tale of two worlds--the TEMISTOCLE study. Am Heart J. 2003 Oct;146(4):E12. doi: 10.1016/S0002-8703(03)00315-6. |
| 16603579 | Background | Tavazzi L, Maggioni AP, Lucci D, Cacciatore G, Ansalone G, Oliva F, Porcu M; Italian survey on Acute Heart Failure Investigators. Nationwide survey on acute heart failure in cardiology ward services in Italy. Eur Heart J. 2006 May;27(10):1207-15. doi: 10.1093/eurheartj/ehi845. Epub 2006 Apr 7. |
| 15812748 | Background | O'Connor CM, Stough WG, Gallup DS, Hasselblad V, Gheorghiade M. Demographics, clinical characteristics, and outcomes of patients hospitalized for decompensated heart failure: observations from the IMPACT-HF registry. J Card Fail. 2005 Apr;11(3):200-5. doi: 10.1016/j.cardfail.2004.08.160. |
| 12633546 | Background | Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, Dietz R, Gavazzi A, Hobbs R, Korewicki J, Madeira HC, Moiseyev VS, Preda I, van Gilst WH, Widimsky J, Freemantle N, Eastaugh J, Mason J; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure survey programme-- a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J. 2003 Mar;24(5):442-63. doi: 10.1016/s0195-668x(02)00823-0. |
| 17707182 | Background | Fonarow GC, Stough WG, Abraham WT, Albert NM, Gheorghiade M, Greenberg BH, O'Connor CM, Sun JL, Yancy CW, Young JB; OPTIMIZE-HF Investigators and Hospitals. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007 Aug 21;50(8):768-77. doi: 10.1016/j.jacc.2007.04.064. Epub 2007 Aug 6. |
| 17447136 | Background | Braunschweig F. Therapeutic and diagnostic role of electrical devices in acute heart failure. Heart Fail Rev. 2007 Jun;12(2):157-66. doi: 10.1007/s10741-007-9019-0. |
| 27118481 | Derived | Vanoli E, Mortara A, Diotallevi P, Gallone G, Mariconti B, Gronda E, Gentili A, Bisetti S, Botto GL. Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study. JMIR Res Protoc. 2016 Apr 26;5(2):e62. doi: 10.2196/resprot.4380. |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |