Brief 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.

Conditions

• Heart Failure

Primary Outcome Measures

• Risk score (From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years)
  Expand and update the patient dataset to further develop the Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score, optimizing its application in specific patient subgroups and aligning it with newly introduced therapies and treatments in clinical practice.
• End point (From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years)
  Time to Cardiovascular death or LVAD implantation or heart transplant

Countries

Italy

Locations and Investigators

• Ospedali Riuniti di Ancona, Ancona, Italy (Recruiting)
  • Maria Vittoria Matassini
• Istituti Clinici Scientifici Maugeri Bari, Bari, Italy (Recruiting)
  • Andrea Passantino
• Ospedale papa Giovanni XXIII, Bergamo, Italy (Recruiting)
  • Annamaria Iorio
• Spedali Civili Brescia, Brescia, Italy (Not yet recruiting)
  • Savina Nodari
• Spedali Civili, Brescia, Italy (Recruiting)
  • Marco Metra
• Università di Foggia, Foggia, Italy (Recruiting)
  • Michele Correale
• Centro Cardiologico Monzino, Milano, Italy (Recruiting)
  • Piergiuseppe Agostoni
• I.R.C.C.S. Ospedale San Raffaele, Milano, Italy (Recruiting)
  • Rosa Raimondo
• IRCCS Istituto Auxologico Italiano, Milano, Italy (Recruiting)
  • Gianfranco Parati
• IRCCS Multimedica- Ospedale San Giuseppe, Milano, Italy (Recruiting)
  • Gaia Cattadori
• Istituti Clinici Scientifici Maugeri Milano, Milano, Italy (Not yet recruiting)
  • Maurizio Bussotti
• Ospedale Cà Granda- A.O. Niguarda, Milano, Italy (Not yet recruiting)
  • Enrico Perna
• Federico II hospital, Naples, Italy (Recruiting)
  • Antonio Cittadini
• Azienda Ospedaliera dei Colli - Ospedale Monaldi, Napoli, Italy (Recruiting)
  • Giuseppe Limongelli
• Università degli Studi di Napoli Federico II, Napoli, Italy (Recruiting)
  • Pasquale Perrone Filardi
• Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione, Palermo, Italy (Not yet recruiting)
• Ospedale Guglielmo da Saliceto, Piacenza, Italy (Recruiting)
  • Francesco Di Spigno
• Fondazione Gabriele Monasterio, Pisa, Italy (Recruiting)
  • Michele Emdin
• Azienda Ospedaliera San Camillo-Forlanini, Roma, Italy (Recruiting)
  • Federica Re
• Azienda Ospedaliera Sant'Andrea, Roma, Italy (Recruiting)
  • Damiano Magrì
• Azienda Ospedaliero-Universitaria Policinico Umberto I, Rome, Italy (Not yet recruiting)
• Santo Spirito Hospital, Rome, Italy (Recruiting)
  • Angela B Scardovi
• IRCCS Policlinico San Donato, San Donato Milanese, Italy (Recruiting)
  • Massimo Piepoli
• S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC), Siena, Italy (Not yet recruiting)
  • Francesca Righini
• S. Maria alle Scotte Hospital UOSA malattie cardiovascolari, Siena, Italy (Not yet recruiting)
  • Alberto Palazzuoli
• Azienda sanitaria universitaria Giuliano Isontina (ASUGI), Trieste, Italy (Recruiting)
  • Gianfranco SInagra