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

March 18, 2025 updated by: Piergiuseppe Agostoni, Centro Cardiologico Monzino

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Heart failure is a complex condition affecting multiple organs beyond the cardiovascular system, influencing disease progression and prognosis. It has become increasingly evident that accurate risk assessment requires considering multiple variables, as no single parameter alone is sufficient for prognosis.

These findings have led to the identification and study of prognostic parameters that, when combined, allow for a more precise risk estimation and identification of high-risk patients. Various prognostic scores have been developed, utilizing algorithms that integrate multiple variables to estimate an individual's mortality risk. Some scores are based on clinical evaluation and comorbidities, others on laboratory findings, baroreflex sensitivity, heart rate, sleep abnormalities, echocardiographic imaging, or cardiopulmonary exercise testing (CPET), either alone or in combination with other factors.

CPET provides several parameters strongly correlated with prognosis. Since the 1990s, its use-alongside clinical data-has been recommended in heart failure management guidelines. More recently, in addition to peak oxygen consumption, the VE/VCO₂ slope has been recognized as a key prognostic marker, reflecting ventilatory efficiency and ventilation-perfusion mismatch, and has been included in heart transplant assessment criteria.

Current risk models in heart failure often omit important prognostic parameters, such as ventilatory indices from CPET, renal function, and hemoglobin levels. Among the numerous prognostic scores available, only the HF Survival Score (HFSS) and the HF Action Predictive Risk Score Model incorporate exercise-related parameters (peak VO₂ in the former and exercise duration in the latter), yet both neglect ventilatory aspects. Even the widely used Seattle Score does not include exercise-related variables.

In 2012, the researchers 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 just six key variables, making it both practical and effective.

Recent studies indicate the need to review and update the cutoff values and parameters used in prognostic models, as the introduction of new therapies and treatment strategies may significantly impact their predictive power in specific patient populations.

Study Objectives and Purpose The aim of this study is to expand and update the patient dataset to further develop the MECKI score, optimizing its application in patient subgroups and adapting it to new therapies and treatments introduced in clinical practice.

Additionally, the researchers seek to determine whether risk prediction accuracy varies in advanced-stage patients, those with comorbidities, or those receiving different treatments. This could lead to the development of correction factors for the MECKI score, improving its predictive power and applicability across different clinical scenarios.

Study Population Patients with systolic heart failure, consecutively enrolled and followed at multiple Heart Failure Units across Italy.

Patients undergo assessment through medical history collection, physical examination, laboratory tests, ECG, transthoracic echocardiography, and cardiopulmonary exercise testing (CPET).

Follow-up will be conducted according to the protocol of the respective Heart Failure Unit. The follow-up period ends at the last evaluation at the reference center, or upon the patient's death or heart transplantation.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ancona, Italy
        • Recruiting
        • Ospedali Riuniti di Ancona
        • Contact:
      • Bari, Italy
      • Bergamo, Italy
        • Recruiting
        • Ospedale Papa Giovanni XXIII
        • Contact:
      • Brescia, Italy
      • Brescia, Italy
      • Foggia, Italy
      • Milano, Italy, 20138
      • Milano, Italy
        • Recruiting
        • IRCCS Istituto Auxologico Italiano
        • Contact:
      • Milano, Italy
        • Recruiting
        • I.R.C.C.S. Ospedale San Raffaele
        • Contact:
      • Milano, Italy
      • Milano, Italy
      • Milano, Italy
      • Naples, Italy
      • Napoli, Italy
        • Recruiting
        • Universita degli Studi di Napoli Federico II
        • Contact:
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera Dei Colli - Ospedale Monaldi
        • Contact:
      • Palermo, Italy
        • Not yet recruiting
        • Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
      • Piacenza, Italy
        • Recruiting
        • Ospedale Guglielmo da Saliceto
        • Contact:
      • Pisa, Italy
        • Recruiting
        • Fondazione Gabriele Monasterio
        • Contact:
      • Roma, Italy
      • Roma, Italy
      • Rome, Italy
        • Not yet recruiting
        • Azienda Ospedaliero-Universitaria Policinico Umberto I
      • Rome, Italy
      • San Donato Milanese, Italy
      • Siena, Italy
        • Not yet recruiting
        • S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC)
        • Contact:
      • Siena, Italy
        • Not yet recruiting
        • S. Maria alle Scotte Hospital UOSA malattie cardiovascolari
        • Contact:
      • Trieste, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with past or present heart failure (with previous documentation of left ventricular systolic dysfunction (LVEF <40%)), in stable clinical conditions, who underwent a cardiopulmonary exercise test, with no scheduled cardiovascular treatment.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Heart failure patients
Patients with systolic heart failure, able to exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk score
Time Frame: 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.
From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years
End point
Time Frame: From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years
Time to Cardiovascular death or LVAD implantation or heart transplant
From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Federico II University
Fondazione Toscana Gabriele Monasterio
Azienda Ospedaliera di Perugia
Istituti Clinici Scientifici Maugeri SpA
Azienda Ospedaliera Niguarda Cà Granda
Monaldi Hospital
Azienda Ospedaliera Universitaria Senese
IRCCS Multimedica
San Raffaele University Hospital, Italy
University of Foggia
Azienda Policlinico Umberto I
S. Andrea Hospital
Santo Spirito Hospital, Italy
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Ospedali Riuniti Ancona
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)
Spedali Civili, University of Brescia, Italy
I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy
Azienda Sanitaria di Firenze
ASST Papa Giovanni XXIII, Bergamo, Italy
Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy
Casa di Cura Mater Dei
Policlinico Bari University Hospital (Bari, Italy)
Policlinico G . Martino, Messina Italy
Ospedale Guglielmo da Saliceto, Piacenza
Città di Lecce Hospital
Ospedale San Luca, Istituto Auxologico Italiano, Milano
Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano
Azienda Ospedaliero-Universitaria Senese

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCM 04-21PA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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