The TOSCA Registry: Hormonal and Metabolic Deficiencies in Chronic Heart Failure
NCT ID: NCT02335801
Last Updated: 2018-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
650 participants
OBSERVATIONAL
2013-04-30
2019-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Hormone Deficiency in Heart Failure With Preserved Ejection Fraction
NCT02976350
Multihormonal Deficiencies and miRNA Profile in Chronic Heart Failure: Effects of Combined Hormonal Replacement Therapy
NCT05769387
Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
NCT06435585
Cardiovascular Risk Factors and LCH in Adults
NCT00483925
New Biomarkers in Heart- and Renal Failure
NCT02830464
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* left ventricle ejection fraction 40% or less
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federico II University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antonio Cittadini
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antonio Cittadini
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, , 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOSCA0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.