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

• Conditions: Chronic Heart Failure

• Registration Number: NCT02335801
• Lead Sponsor: Federico II University

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.

Detailed 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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-12
• Primary Completion: 2015-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality and hospitalization	every six months (up to 5 years)	outcome assessed during scheduled visits or phone calls

Secondary Outcome Measures

Name	Time	Method
cardiovascular mortality	every six months (up to 5 years)	outcome assessed during scheduled visits or phone calls
cardiovascular hospitalizations	every six months (up to 5 years)	outcome assessed during scheduled visits or phone calls

Trial Locations

Locations (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, Italy

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