A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score

Conditions
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HF - Heart Failure

Intervention / Treatment
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* Diagnostic Test: CPET and related variables evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sigle arm study<br>HF patients who meets all the inclusion and none of the exclusion criteria | Diagnostic Test: CPET and related variables evaluation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day-by-day variability of MECKI score | 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. | through study completion, an average of 3 year | 
| Identification of interobserver variability | CPET interobservers variability will be done by assessing CPET analysis done by two recognized CPET experts blinded on patients data | through study completion, an average of 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-related dynamic changes of peak oxygen intake (VO2) | Modifications in peak oxygen intake (VO2) in 6-12-18-24 months will be evaluated in relation to prognosis | through study completion, an average of 3 year | 
| Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope | Modifications in minute ventilation/carbon dioxide production (VE/VCO2) slope in 6-12-18-24 months will be evaluated in relation to prognosis | through study completion, an average of 3 year | 
| Time-related dynamic changes of MDRD | Modifications of MDRD in 6-12-18-24 months will be evaluated in relation to prognosis | through study completion, an average of 3 year | 
| Time-related dynamic changes of LVEF | Modifications of LVEF in 6-12-18-24 months will be evaluated in relation to prognosis | through study completion, an average of 3 year | 
| Time-related dynamic changes of hemoglobin | Modifications of hemoglobin in 6-12-18-24 months will be evaluated in relation to prognosis | through study completion, an average of 3 year | 
| Time-related dynamic changes of Na+ | Modifications of Na+ in 6-12-18-24 months will be evaluated in relation to prognosis | through study completion, an average of 3 year | 
| The identification of the prognostic meaning of MECKI score changes at 6 months | Modifications of MECKI score at 6 months will be evaluated in relation to prognosis | 6 months | 
| The identification of the prognostic meaning of MECKI score changes at one year | Modifications of MECKI score at one year will be evaluated in relation to prognosis | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary exercise testing- CPET, Metabolic Exercise Cardiac Kidney Indexes (MECKI) score