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

Study Overview
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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

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

Conditions
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Chronic Heart Failure

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality and hospitalization | outcome assessed during scheduled visits or phone calls | every six months (up to 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular mortality | outcome assessed during scheduled visits or phone calls | every six months (up to 5 years) | 
| cardiovascular hospitalizations | outcome assessed during scheduled visits or phone calls | every six months (up to 5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, growth hormone, testosterone, insulin resistance, thyroid hormones, survival