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The TOSCA Registry: Hormonal and Metabolic Deficiencies in Chronic Heart Failure

NCT ID: NCT02335801

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Chronic Heart Failure

Keywords

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heart failure growth hormone testosterone insulin resistance thyroid hormones survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* patients of either sex affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
* left ventricle ejection fraction 40% or less

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Antonio Cittadini

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antonio Cittadini

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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U.O. di Cardiologia 2 IRCCS-Istituto Scientifico di Riabilitazione di Cassano delle Murge

Cassano delle Murge, Bari, Italy

Site Status RECRUITING

Santa Maria della Pietà Hospital

Nola, Napoli, Italy

Site Status RECRUITING

Policlinico di Bari

Bari, , Italy

Site Status RECRUITING

Policlinico "Vittorio Emanuele" University of Catania

Catania, , Italy

Site Status RECRUITING

Unità Operativa di Malattie Cardiovascolari del Policlinico Mater Domini

Catanzaro, , Italy

Site Status RECRUITING

UOC di Medicina Interna IRCCS Oasi Maria SS

Enna, , Italy

Site Status RECRUITING

UOC Clinica Medica Dipartimento ad Attività Integrata di Medicina Azienda Ospedaliera-Universitaria S.Anna

Ferrara, , Italy

Site Status RECRUITING

University of Florence

Florence, , Italy

Site Status NOT_YET_RECRUITING

IRCCS Policlinico San Donato Milanese

Milan, , Italy

Site Status RECRUITING

Department of Traslational Sciences - Federico II University

Naples, , Italy

Site Status RECRUITING

AORN V. Monaldi SUN - Centro di diagnosi e cura Cardiomiopatie e Scompenso Cardiaco

Napoli, , Italy

Site Status RECRUITING

Dipartimento di Scienze Biomediche Avanzate Università degli studi di Napoli Federico II

Napoli, , Italy

Site Status RECRUITING

U.O.S. Endocrinologia Ospedali Riuniti "Villa Sofia - Cervello"

Palermo, , Italy

Site Status NOT_YET_RECRUITING

U.O. di Riabilitazione Cardiologica IRCCS S. Raffaele Pisana

Rome, , Italy

Site Status RECRUITING

UOC Endocrinologia e Malattie del Metabolismo Policlinico Universitario Gemelli

Rome, , Italy

Site Status RECRUITING

U.O. di Cardiologia e UTIC Ospedale S. Maria Incoronata dell'Olmo

Salerno, , Italy

Site Status RECRUITING

Medicina Generale ad Indirizzo Endocrinologico - d.O. Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Antonio Cittadini, Professor

Role: CONTACT

Phone: +39 081 7464375

Email: [email protected]

Michele Arcopinto, MD

Role: CONTACT

Phone: + 39 3397707531

Email: [email protected]

Facility Contacts

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Andrea Passantino, MD

Role: primary

Luigi Caliendo, MD

Role: primary

Luciano Carbone, MD

Role: backup

Massimo Iacoviello, MD

Role: primary

Vincenzo Triggiani, MD

Role: backup

Ines Monte, MD

Role: primary

Francesco Perticone

Role: primary

Antonio Belfiore

Role: backup

Letizia Ragusa, MD

Role: primary

Roberto Manfredini, MD

Role: primary

Pietro Amedeo Modesti, MD

Role: primary

Michele Arcopinto, MD

Role: primary

Antonio Cittadini, MD

Role: primary

Michele Arcopinto, MD

Role: backup

Giuseppe Limongelli, MD

Role: primary

Pasquale Perrone-Filardi, MD

Role: primary

Graziella Malizia, MD

Role: primary

Piernicola Garofalo, MD

Role: backup

Maurizio Volterrani, MD

Role: primary

Antonio Mancini, MD

Role: primary

Eduardo Bossone, MD, PhD

Role: primary

Francesco Ferrara, MD

Role: backup

Roberto Castello, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19584187 (View on PubMed)

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.

Reference Type RESULT
PMID: 22567736 (View on PubMed)

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.

Reference Type RESULT
PMID: 25037691 (View on PubMed)

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.

Reference Type RESULT
PMID: 24621936 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35710369 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33693736 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29619769 (View on PubMed)

Other Identifiers

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TOSCA0001

Identifier Type: -

Identifier Source: org_study_id