About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Centro Cardiologico Monzino
Lead sponsor
Santo Spirito Hospital, Italy
Collaborator
Fondazione Toscana Gabriele Monasterio
Collaborator
Spedali Civili, University of Brescia, Italy
Collaborator
Monaldi Hospital
Collaborator
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Collaborator
San Raffaele University Hospital, Italy
Collaborator
University of Foggia
Collaborator
Azienda Ospedaliera Niguarda Cà Granda
Collaborator
Azienda Policlinico Umberto I
Collaborator
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
Collaborator
Città di Lecce Hospital
Collaborator
Policlinico G . Martino, Messina Italy
Collaborator
Azienda Ospedaliera Universitaria Senese
Collaborator
Azienda Sanitaria di Firenze
Collaborator
Ospedale San Luca, Istituto Auxologico Italiano, Milano
Collaborator
Casa di Cura Mater Dei
Collaborator
University of Bari
Collaborator
Azienda Ospedaliera di Perugia
Collaborator
I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
Collaborator
IRCCS Multimedica
Collaborator
Ospedali Riuniti Ancona
Collaborator
A.O. Ospedale Papa Giovanni XXIII
Collaborator
S. Andrea Hospital
Collaborator
Istituti Clinici Scientifici Maugeri SpA
Collaborator
Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano
Collaborator
Azienda Ospedaliero-Universitaria Senese
Collaborator
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Collaborator
Federico II University
Collaborator
Ospedale Guglielmo da Saliceto, Piacenza
Collaborator