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The objective of this study is to determine whether the presence of metabolic alteration and anabolic deficiencies in patients with chronic heart failure are able to identify a subset of patients with poor outcome.
Despite the effectiveness of the neurohormonal model to explain the progression of heart failure and the many insights that it provided for the development of new therapies, there is increasing clinical evidence that suggests that our current models fail to completely explain the disease progression. Thus, neurohormonal models may be necessary but not sufficient to explain all aspects of disease progression in the failing heart. There is evidence suggesting that in heart failure there is a metabolic imbalance characterized by the predominance of the catabolic status over the anabolic drive.
Aim of this registry is to determine the prevalence of hormone/metabolic deficiencies in heart failure patients and to look for possible association with clinical variables. Moreover, enrolled patients will be followed up for a mean of 2,5 years in order to collect outcome data including all-cause mortality, cardiovascular mortality, hospitalizations.
This is a multi-center observational study involving several Italian Department of Cardiology, Endocrinology, Internal Medicine
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| Measure | Description | Time Frame |
|---|---|---|
| all-cause mortality and hospitalization | outcome assessed during scheduled visits or phone calls | every six months (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| cardiovascular mortality | outcome assessed during scheduled visits or phone calls | every six months (up to 5 years) |
| cardiovascular hospitalizations | outcome assessed during scheduled visits or phone calls |
| Measure | Description | Time Frame |
|---|---|---|
| reduction in peak oxygen consumption | outcome assessed during scheduled visits | every six months (up to 5 years) |
| left ventricular volumes | outcome assessed during scheduled visits |
Inclusion Criteria:
Exclusion Criteria:
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patients with stable chronic heart failure with reduced ejection fraction
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Cittadini, Professor | Contact | +39 081 7464375 | antonio.cittadini@unina.it | |
| Michele Arcopinto, MD | Contact | + 39 3397707531 | michele.arcopinto83@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Cittadini | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O. di Cardiologia 2 IRCCS-Istituto Scientifico di Riabilitazione di Cassano delle Murge | Recruiting | Cassano delle Murge | Bari | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19584187 | Background | Cittadini A, Saldamarco L, Marra AM, Arcopinto M, Carlomagno G, Imbriaco M, Del Forno D, Vigorito C, Merola B, Oliviero U, Fazio S, Sacca L. Growth hormone deficiency in patients with chronic heart failure and beneficial effects of its correction. J Clin Endocrinol Metab. 2009 Sep;94(9):3329-36. doi: 10.1210/jc.2009-0533. Epub 2009 Jul 7. | |
| 22567736 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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serum for determination of hormonal levels
| every six months (up to 5 years) |
| every six months (up to 5 years) |
| Santa Maria della Pietà Hospital | Recruiting | Nola | Napoli | Italy |
|
| Policlinico di Bari | Recruiting | Bari | Italy |
|
| Policlinico "Vittorio Emanuele" University of Catania | Recruiting | Catania | Italy |
|
| Unità Operativa di Malattie Cardiovascolari del Policlinico Mater Domini | Recruiting | Catanzaro | Italy |
|
| UOC di Medicina Interna IRCCS Oasi Maria SS | Recruiting | Enna | Italy |
|
| UOC Clinica Medica Dipartimento ad Attività Integrata di Medicina Azienda Ospedaliera-Universitaria S.Anna | Recruiting | Ferrara | Italy |
|
| University of Florence | Not yet recruiting | Florence | Italy |
|
| IRCCS Policlinico San Donato Milanese | Recruiting | Milan | Italy |
|
| Department of Traslational Sciences - Federico II University | Recruiting | Naples | 80100 | Italy |
|
| AORN V. Monaldi SUN - Centro di diagnosi e cura Cardiomiopatie e Scompenso Cardiaco | Recruiting | Naples | Italy |
|
| Dipartimento di Scienze Biomediche Avanzate Università degli studi di Napoli Federico II | Recruiting | Naples | Italy |
|
| U.O.S. Endocrinologia Ospedali Riuniti "Villa Sofia - Cervello" | Not yet recruiting | Palermo | Italy |
|
| U.O. di Riabilitazione Cardiologica IRCCS S. Raffaele Pisana | Recruiting | Rome | Italy |
|
| UOC Endocrinologia e Malattie del Metabolismo Policlinico Universitario Gemelli | Recruiting | Rome | Italy |
|
| U.O. di Cardiologia e UTIC Ospedale S. Maria Incoronata dell'Olmo | Recruiting | Salerno | Italy |
|
| Medicina Generale ad Indirizzo Endocrinologico - d.O. Azienda Ospedaliera Universitaria Integrata | Recruiting | Verona | Italy |
|
| Bossone E, Limongelli G, Malizia G, Ferrara F, Vriz O, Citro R, Marra AM, Arcopinto M, Bobbio E, Sirico D, Caliendo L, Ballotta A, D'Andrea A, Frigiola A, Isgaard J, Sacca L, Antonio C; T.O.S.CA. Investigators. The T.O.S.CA. Project: research, education and care. Monaldi Arch Chest Dis. 2011 Dec;76(4):198-203. doi: 10.4081/monaldi.2011.177. |
| 25037691 | Result | Arcopinto M, Isgaard J, Marra AM, Formisano P, Bossone E, Vriz O, Vigorito C, Sacca L, Douglas PS, Cittadini A. IGF-1 predicts survival in chronic heart failure. Insights from the T.O.S.CA. (Trattamento Ormonale Nello Scompenso CArdiaco) registry. Int J Cardiol. 2014 Oct 20;176(3):1006-8. doi: 10.1016/j.ijcard.2014.07.003. Epub 2014 Jul 11. No abstract available. |
| 24621936 | Result | Cittadini A, Marra AM, Arcopinto M, Bobbio E, Salzano A, Sirico D, Napoli R, Colao A, Longobardi S, Baliga RR, Bossone E, Sacca L. Growth hormone replacement delays the progression of chronic heart failure combined with growth hormone deficiency: an extension of a randomized controlled single-blind study. JACC Heart Fail. 2013 Aug;1(4):325-330. doi: 10.1016/j.jchf.2013.04.003. Epub 2013 Aug 5. |
| 35710369 | Derived | Salzano A, D'Assante R, Iacoviello M, Triggiani V, Rengo G, Cacciatore F, Maiello C, Limongelli G, Masarone D, Sciacqua A, Filardi PP, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Arcopinto M, Gargiulo P, Perticone M, Colao A, Milano S, Garavaglia A, Napoli R, Suzuki T, Bossone E, Marra AM, Cittadini A; T.O.S.CA. Investigators. Progressive right ventricular dysfunction and exercise impairment in patients with heart failure and diabetes mellitus: insights from the T.O.S.CA. Registry. Cardiovasc Diabetol. 2022 Jun 16;21(1):108. doi: 10.1186/s12933-022-01543-3. |
| 33693736 | Derived | Cittadini A, Salzano A, Iacoviello M, Triggiani V, Rengo G, Cacciatore F, Maiello C, Limongelli G, Masarone D, Perticone F, Cimellaro A, Perrone Filardi P, Paolillo S, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Monte IP, Puzzo A, Ballotta A, D'Assante R, Arcopinto M, Gargiulo P, Sciacqua A, Bruzzese D, Colao A, Napoli R, Suzuki T, Eagle KA, Ventura HO, Marra AM, Bossone E; T.O.S.CA. Investigators. Multiple hormonal and metabolic deficiency syndrome predicts outcome in heart failure: the T.O.S.CA. Registry. Eur J Prev Cardiol. 2021 Dec 29;28(15):1691-1700. doi: 10.1093/eurjpc/zwab020. |
| 29619769 | Derived | Bossone E, Arcopinto M, Iacoviello M, Triggiani V, Cacciatore F, Maiello C, Limongelli G, Masarone D, Perticone F, Sciacqua A, Perrone-Filardi P, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Monte I, Puzzo A, Ballotta A, Caliendo L, D'Assante R, Marra AM, Salzano A, Suzuki T, Cittadini A; TOSCA Investigators. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry. Intern Emerg Med. 2018 Aug;13(5):661-671. doi: 10.1007/s11739-018-1844-8. Epub 2018 Apr 4. |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |