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

F

Federico II University

Status

Unknown

Conditions

Chronic Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT02335801
TOSCA0001

Details and patient eligibility

About

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.

Full 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

Enrollment

650 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

17

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Central trial contact

Antonio Cittadini, Professor; Michele Arcopinto, MD

Data sourced from clinicaltrials.gov

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