Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure
NCT06884631 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000
Last updated 2025-03-19
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
Sponsors & Collaborators
-
Santo Spirito Hospital, Italy
collaborator OTHER -
Fondazione Toscana Gabriele Monasterio
collaborator OTHER -
Spedali Civili, University of Brescia, Italy
collaborator UNKNOWN -
Monaldi Hospital
collaborator OTHER -
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
collaborator UNKNOWN -
San Raffaele University Hospital, Italy
collaborator OTHER -
University of Foggia
collaborator OTHER -
Azienda Ospedaliera Niguarda Cà Granda
collaborator OTHER -
Azienda Policlinico Umberto I
collaborator OTHER -
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
collaborator UNKNOWN -
Città di Lecce Hospital
collaborator UNKNOWN -
Policlinico G . Martino, Messina Italy
collaborator UNKNOWN -
Azienda Ospedaliera Universitaria Senese
collaborator OTHER -
Azienda Sanitaria di Firenze
collaborator OTHER -
Ospedale San Luca, Istituto Auxologico Italiano, Milano
collaborator UNKNOWN -
Casa di Cura Mater Dei
collaborator UNKNOWN -
University of Bari
collaborator OTHER -
Azienda Ospedaliera di Perugia
collaborator OTHER -
I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
collaborator UNKNOWN -
IRCCS Multimedica
collaborator OTHER -
Ospedali Riuniti Ancona
collaborator OTHER -
ASST Papa Giovanni XXIII, Bergamo, Italy
collaborator UNKNOWN -
S. Andrea Hospital
collaborator OTHER -
Istituti Clinici Scientifici Maugeri SpA
collaborator OTHER -
Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano
collaborator UNKNOWN -
Azienda Ospedaliero-Universitaria Senese
collaborator UNKNOWN -
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
collaborator OTHER -
Federico II University
collaborator OTHER -
Ospedale Guglielmo da Saliceto, Piacenza
collaborator UNKNOWN -
Centro Cardiologico Monzino
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-10
- Primary Completion
- 2026-12-31
- Completion
- 2028-12-31
Countries
- Italy
Study Locations
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