A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
Centro Cardiologico Monzino
400 participants
May 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria6
- 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
Interventions
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, it will be performed: * Echocardiography (LVEF) * Blood sample (Na+, MDRD, Hb) * Maximal ramp protocol CPET (peakVO2, VE/VCO2 slope)
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06070519