The TOSCA Registry: Hormonal and Metabolic Deficiencies in Chronic Heart Failure
TOSCA
The TOSCA Registry: Epidemiology, Clinical and Prognostic Value of Hormonal and Metabolic Deficiencies in Chronic Heart Failure
1 other identifier
observational
650
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2014
CompletedFirst Posted
Study publicly available on registry
January 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 13, 2018
December 1, 2018
2.2 years
December 9, 2014
December 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all-cause mortality and hospitalization
outcome assessed during scheduled visits or phone calls
every six months (up to 5 years)
Secondary Outcomes (2)
cardiovascular mortality
every six months (up to 5 years)
cardiovascular hospitalizations
every six months (up to 5 years)
Other Outcomes (2)
reduction in peak oxygen consumption
every six months (up to 5 years)
left ventricular volumes
every six months (up to 5 years)
Eligibility Criteria
patients with stable chronic heart failure with reduced ejection fraction
You may qualify if:
- patients of either sex affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
- left ventricle ejection fraction 40% or less
You may not qualify if:
- severe liver disease
- serum creatinine levels \>2.5 mg/dl
- history of active cancer with life expectancy below 1 year
- acute coronary syndrome in the previous 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
U.O. di Cardiologia 2 IRCCS-Istituto Scientifico di Riabilitazione di Cassano delle Murge
Cassano delle Murge, Bari, Italy
Santa Maria della Pietà Hospital
Nola, Napoli, Italy
Policlinico di Bari
Bari, Italy
Policlinico "Vittorio Emanuele" University of Catania
Catania, Italy
Unità Operativa di Malattie Cardiovascolari del Policlinico Mater Domini
Catanzaro, Italy
UOC di Medicina Interna IRCCS Oasi Maria SS
Enna, Italy
UOC Clinica Medica Dipartimento ad Attività Integrata di Medicina Azienda Ospedaliera-Universitaria S.Anna
Ferrara, Italy
University of Florence
Florence, Italy
IRCCS Policlinico San Donato Milanese
Milan, Italy
Department of Traslational Sciences - Federico II University
Naples, 80100, Italy
AORN V. Monaldi SUN - Centro di diagnosi e cura Cardiomiopatie e Scompenso Cardiaco
Napoli, Italy
Dipartimento di Scienze Biomediche Avanzate Università degli studi di Napoli Federico II
Napoli, Italy
U.O.S. Endocrinologia Ospedali Riuniti "Villa Sofia - Cervello"
Palermo, Italy
U.O. di Riabilitazione Cardiologica IRCCS S. Raffaele Pisana
Rome, Italy
UOC Endocrinologia e Malattie del Metabolismo Policlinico Universitario Gemelli
Rome, Italy
U.O. di Cardiologia e UTIC Ospedale S. Maria Incoronata dell'Olmo
Salerno, Italy
Medicina Generale ad Indirizzo Endocrinologico - d.O. Azienda Ospedaliera Universitaria Integrata
Verona, Italy
Related Publications (7)
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.
PMID: 19584187BACKGROUNDBossone 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.
PMID: 22567736RESULTArcopinto 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.
PMID: 25037691RESULTCittadini 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.
PMID: 24621936RESULTSalzano 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.
PMID: 35710369DERIVEDCittadini 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.
PMID: 33693736DERIVEDBossone 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.
PMID: 29619769DERIVED
Biospecimen
serum for determination of hormonal levels
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Cittadini
Federico II University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 9, 2014
First Posted
January 12, 2015
Study Start
April 1, 2013
Primary Completion
June 1, 2015
Study Completion
December 1, 2019
Last Updated
December 13, 2018
Record last verified: 2018-12