A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- Day-by-day variability of MECKI score
研究概览
简要总结
The project is dedicated to the improvement of our capability to provide a precise and personalized prognosis in heart failure (HF) patients in stable conditions. The Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score is one of the 3 HF prognostic models recommended by the 2021 European HF guidelines and it is considered the most powerful prognostic tool available. MECKI score integrates cardiopulmonary exercise test (CPET) data with easy-to-obtain clinical, laboratory, and echocardiographic variables. It is based on 6 parameters: peak oxygen intake (peakVO2), minute ventilation/carbon dioxide production (VE/VCO2 slope), hemoglobin (Hb), Left Ventricle Ejection Fraction (LVEF), kidney function by Modification of Diet in Renal Disease (MDRD) formula, and sodium (Na+).
The aim of the present project is to assess the day-by-day MECKI score variability, CPET parameters interobserver variability, characterization of HF patients who change MECKI score values in 6 and 12 months, and the prognostic meaning of time dependent MECKI score changes.
详细描述
This is a low-intervention multicenter clinical trial aim at evaluating the role of time dependent prognostic parameters changes, moving from the single shot evaluation to dynamic analysis. Each participant center will perform patients' recruitment and follow up. At the baseline visit, CPET-related variables, echocardiographic, ECG, therapy and blood chemistry data will be collected. The baseline CPET will be repeated within 2 weeks. Patients will perform 4 follow up visits at 6, 12, 18 and 24 months after the baseline visit. At every study step, study procedures aimed to calculate MECKI score will be performed:
- Echocardiography (Left Ventricle Ejection Fraction - LVEF)
- Blood sample (Na+, MDRD, Hb)
- Maximal ramp protocol CPET (peakVO2, minute ventilation/carbon dioxide production (VE/VCO2) slope - VE/VCO2 slope)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Previous or present HF symptoms (NYHA functional class I-IV, stage B and C of ACC/AHA classification)
- •history or presence of left ventricular ejection fraction (LVEF)<40%
- •unchanged HF medications for at least three months
- •ability to perform a CPET
- •no major cardiovascular treatment or intervention scheduled
排除标准
- •History of pulmonary embolism
- •moderate-to-severe aortic and mitral stenosis
- •pericardial disease
- •severe obstructive lung disease
- •exercise-induced angina
- •significant ECG alterations, or presence of any clinical comorbidity interfering with exercise performance
结局指标
主要结局
Day-by-day variability of MECKI score
时间窗: through study completion, an average of 3 year
Day by day variability of MECKI score will be done by comparing MECKI score value obtained at study run-in (day 0) and in a second evaluation of MECKI score performed within 2 weeks.
Identification of interobserver variability
时间窗: through study completion, an average of 3 year
CPET interobservers variability will be done by assessing CPET analysis done by two recognized CPET experts blinded on patients data
次要结局
- Time-related dynamic changes of hemoglobin(through study completion, an average of 3 year)
- Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope(through study completion, an average of 3 year)
- The identification of the prognostic meaning of MECKI score changes at 6 months(6 months)
- Time-related dynamic changes of MDRD(through study completion, an average of 3 year)
- The identification of the prognostic meaning of MECKI score changes at one year(one year)
- Time-related dynamic changes of peak oxygen intake (VO2)(through study completion, an average of 3 year)
- Time-related dynamic changes of LVEF(through study completion, an average of 3 year)
- Time-related dynamic changes of Na+(through study completion, an average of 3 year)