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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02335801
Acronym
TOSCA
Enrollment
650
Registered
2015-01-12
Start date
2013-04-30
Completion date
2019-12-01
Last updated
2018-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Keywords

heart failure, growth hormone, testosterone, insulin resistance, thyroid hormones, survival

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

Interventions

None listed

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
all-cause mortality and hospitalizationevery six months (up to 5 years)outcome assessed during scheduled visits or phone calls

Secondary

MeasureTime frameDescription
cardiovascular mortalityevery six months (up to 5 years)outcome assessed during scheduled visits or phone calls
cardiovascular hospitalizationsevery six months (up to 5 years)outcome assessed during scheduled visits or phone calls

Other

MeasureTime frameDescription
reduction in peak oxygen consumptionevery six months (up to 5 years)outcome assessed during scheduled visits
left ventricular volumesevery six months (up to 5 years)outcome assessed during scheduled visits

Countries

Italy

Contacts

Primary ContactAntonio Cittadini, Professor
antonio.cittadini@unina.it+39 081 7464375
Backup ContactMichele Arcopinto, MD
michele.arcopinto83@gmail.com+ 39 3397707531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026