Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure
Recruiting · NCT06884631 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centro Cardiologico Monzino
View the official record on ClinicalTrials.gov →What this trial is about
Heart failure is a complex condition involving multiple organs beyond the cardiovascular system, all influencing disease progression and prognosis. Accurate risk assessment requires considering multiple variables, as no single parameter alone provides a complete prognostic picture. This has led to the development of prognostic models combining clinical and laboratory parameters. Some of these models incorporate cardiopulmonary exercise testing (CPET), which provides key prognostic indicators. Since the 1990s, CPET has been recommended in heart failure management guidelines due to its strong prognostic value when combined with clinical data. However, existing risk models often exclude important predictors such as ventilatory parameters from CPET (VE/VCO₂), renal function, and hemoglobin levels. To address this gap, in 2012 the investigators developed the MECKI (Metabolic Exercise test data combined with Cardiac and Kidney Indexes) score, integrating oxygen consumption, ventilatory efficiency, and easily accessible biochemical and echocardiographic parameters. Unlike previous models requiring extensive data collection, MECKI is based on only six variables, making it practical and effective. Recent studies suggest the need to update the cutoff values and parameters used for risk stratification, as new therapies and treatment strategies may significantly alter prognostic accuracy in different patient populations. This study aims to expand and refine the MECKI score by updating the patient dataset, optimizing its performance in specific subgroups, and aligning it with emerging therapeutic approaches. Additionally, the investigators will evaluate whether the model's risk accuracy varies in advanced-stage patients, those with comorbidities, or under different treatment regimens. This could lead to correction factors that enhance the score's predictive power across diverse clinical scenarios, further improving its applicability and reliability in heart failure management.
Who can take part
Inclusion criteria
- age \>18 past or present heart failure (NYHA functional class I-III, stage C of the ACC/AHA classification)
- documentation of left ventricular systolic dysfunction (LVEF \<40%)
- stable clinical conditions
- previous or concomitant cardiopulmonary exercise test
Exclusion criteria
- scheduled cardiovascular treatment
- clinical unstable condition
- History of pulmonary embolism, significant valvular disease, pericardial disease, severe COPD, exercise-induced angina, exercise-induced ECG changes, severe brady- or tachyarrhythmias, or the presence of comorbidities that interfere with exercise performance.
Where it is running
26 locations listed.
- Ospedali Riuniti di Ancona - Ancona, Italy
- Istituti Clinici Scientifici Maugeri Bari - Bari, Italy
- Ospedale papa Giovanni XXIII - Bergamo, Italy
- Spedali Civili Brescia - Brescia, Italy
- Spedali Civili - Brescia, Italy
- Università di Foggia - Foggia, Italy
- I.R.C.C.S. Ospedale San Raffaele - Milan, Italy
- IRCCS Istituto Auxologico Italiano - Milan, Italy
- IRCCS Multimedica- Ospedale San Giuseppe - Milan, Italy
- Istituti Clinici Scientifici Maugeri Milano - Milan, Italy
- Ospedale Cà Granda- A.O. Niguarda - Milan, Italy
- Azienda Ospedaliera dei Colli - Ospedale Monaldi - Naples, Italy
- Federico II hospital - Naples, Italy
- Università degli Studi di Napoli Federico II - Naples, Italy
- Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione - Palermo, Italy
- Ospedale Guglielmo da Saliceto - Piacenza, Italy
- Fondazione Gabriele Monasterio - Pisa, Italy
- Azienda Ospedaliera San Camillo-Forlanini - Roma, Italy
- Azienda Ospedaliera Sant'Andrea - Roma, Italy
- Azienda Ospedaliero-Universitaria Policinico Umberto I - Rome, Italy
- Santo Spirito Hospital - Rome, Italy
- IRCCS Policlinico San Donato - San Donato Milanese, Italy
- S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC) - Siena, Italy
- S. Maria alle Scotte Hospital UOSA malattie cardiovascolari - Siena, Italy
- Azienda sanitaria universitaria Giuliano Isontina (ASUGI) - Trieste, Italy
- Centro Cardiologico Monzino - Milan, Italy, Italy