Clinical and Echocardiographic Management of Patients With Chronic Heart Failure and Type 2 Diabetes Mellitus: the SCODIAC Follow up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Total Cholesterol, LDL, HDL Triglycerides, Creatinine
研究概览
简要总结
The study has been carried out to determine diagnostic and therapeutic pathways in a group of HF diabetic patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy.
详细描述
406 patients affected with heart failure and Type 2 Diabetes Mellitus, referred to Cardiologists and Diabetologists of pertaining healthcare districts in Campania, and followed for at least one year between 2018 and 2019, were enrolled in this retrospective study and divided in Group A, composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (>45%) and Group B, formed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%). All patients had performed periodic clinical evaluations and an echocardiographic exam every 12 months. Anthropometric parameters, HF etiology, co-morbidities, complications and ongoing therapies were collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age at least 65 years
- •presence of chronic HF, defined as a stable clinical syndrome with typical symptoms and signs and echocardiographic evidence of cardiac involvement
- •New York Heart Association (NYHA) class II-III
- •diagnosis of T2DM from at least 2 years
排除标准
- •cardiac surgery performed during the last year
- •age less than 65 years
- •significant valvulopathies
- •malignant neoplasms
- •advanced chronic kidney disease
研究组 & 干预措施
diabetic HF-pEF patients
It is composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (>45%).
干预措施: Antidiabetic (Drug)
diabetic HF-rEF patients
It is composed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%).
干预措施: Antidiabetic (Drug)
结局指标
主要结局
Total Cholesterol, LDL, HDL Triglycerides, Creatinine
时间窗: 12 months
mg/dl
B-type natriuretic peptide (BNP)
时间窗: 12 months
pmol/m
HbA1c
时间窗: 12 months
mmol/L
Ejection Fraction
时间窗: 12 months
Left Ventricular End-Diastolic Volume Index (LV-EDVi), Left Ventricular End-Systolic Volume Index (LV-ESVi), Left Atrial Volume Index (LAVi)
时间窗: 12 months
ml/m2
E velocity, A velocity,E' velocity
时间窗: 12 months
m/sec
次要结局
未报告次要终点
研究者
Oliviero Ugo
Principal investigator
Federico II University