RecruitingNCT06884631

Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure

Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure


Sponsor

Centro Cardiologico Monzino

Enrollment

10,000 participants

Start Date

Feb 10, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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.

Locations(26)

Centro Cardiologico Monzino

Milan, Italy, Italy

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

Federico II hospital

Naples, Italy

Azienda Ospedaliera dei Colli - Ospedale Monaldi

Napoli, Italy

Università degli Studi di Napoli Federico II

Napoli, 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06884631


Related Trials