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

Chronic Heart Failure Clinical Trial

— TOSCA  

Official title:

The TOSCA Registry: Epidemiology, Clinical and Prognostic Value of Hormonal and Metabolic Deficiencies in Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02335801
• Other study ID #: TOSCA0001
• Status: Recruiting
• Start date: April 2013
• Est. completion date: December 1, 2019

Study information

• Verified date: December 2018
• Source: Federico II University
• Contact: Antonio Cittadini, Professor
• Phone: +39 081 7464375
• Email: antonio.cittadini[@]unina.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 1, 2019
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Italy	Policlinico di Bari	Bari
Italy	U.O. di Cardiologia 2 IRCCS-Istituto Scientifico di Riabilitazione di Cassano delle Murge	Cassano delle Murge	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	Santa Maria della Pietà Hospital	Nola	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

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Arcopinto M, Isgaard J, Marra AM, Formisano P, Bossone E, Vriz O, Vigorito C, Saccà 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 C — View Citation

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, Saccà L, Antonio C; T.O.S.CA. Investigators. The T.O.S.CA. Project: research, education a — View Citation

Cittadini A, Marra AM, Arcopinto M, Bobbio E, Salzano A, Sirico D, Napoli R, Colao A, Longobardi S, Baliga RR, Bossone E, Saccà L. Growth hormone replacement delays the progression of chronic heart failure combined with growth hormone deficiency: an exten — View Citation

Cittadini A, Saldamarco L, Marra AM, Arcopinto M, Carlomagno G, Imbriaco M, Del Forno D, Vigorito C, Merola B, Oliviero U, Fazio S, Saccà 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	reduction in peak oxygen consumption	outcome assessed during scheduled visits	every six months (up to 5 years)
Other	left ventricular volumes	outcome assessed during scheduled visits	every six months (up to 5 years)
Primary	all-cause mortality and hospitalization	outcome assessed during scheduled visits or phone calls	every six months (up to 5 years)
Secondary	cardiovascular mortality	outcome assessed during scheduled visits or phone calls	every six months (up to 5 years)
Secondary	cardiovascular hospitalizations	outcome assessed during scheduled visits or phone calls	every six months (up to 5 years)