NCT02335801

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
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Heart Failure

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-06-01
• Completion: 2019-12-01
• First posted: 2015-01-12
• Last updated: 2018-12-13

Locations

17 sites across 1 country: Italy