The TOSCA Registry: Epidemiology, Clinical and Prognostic Value of Hormonal and Metabolic Deficiencies in Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 650
- 试验地点
- 17
- 主要终点
- all-cause mortality and hospitalization
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients of either sex affected by CHF, secondary to ischemic or idiopathic dilated cardiomyopathy
- •left ventricle ejection fraction 40% or less
排除标准
- •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
结局指标
主要结局
all-cause mortality and hospitalization
时间窗: every six months (up to 5 years)
outcome assessed during scheduled visits or phone calls
次要结局
- cardiovascular mortality(every six months (up to 5 years))
- cardiovascular hospitalizations(every six months (up to 5 years))
研究者
Antonio Cittadini
Associate Professor
Federico II University