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

Centro Cardiologico Monzino400 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

IRCCS Centro Cardiologico Monzino

Milan, Milan, Italy

RECRUITING

Università di Napoli Federico II

Naples, Italy

RECRUITING

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, Italy

NOT_YET_RECRUITING

Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica

Pisa, Italy

RECRUITING

Outcomes

Primary Outcomes

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.