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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06884631 on ClinicalTrials.gov