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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 1 trial group
Group A: Heart failure patients

Trial outcomes

Primary outcomes

1

Risk score

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.

Time frame
From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years
2

End point

Time to Cardiovascular death or LVAD implantation or heart transplant

Time frame
From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro Cardiologico Monzino

Lead sponsor

Santo Spirito Hospital, Italy

Collaborator

Fondazione Toscana Gabriele Monasterio

Collaborator

Spedali Civili, University of Brescia, Italy

Collaborator

Monaldi Hospital

Collaborator

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

Collaborator

San Raffaele University Hospital, Italy

Collaborator

University of Foggia

Collaborator

Azienda Ospedaliera Niguarda Cà Granda

Collaborator

Azienda Policlinico Umberto I

Collaborator

Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy

Collaborator

Città di Lecce Hospital

Collaborator

Policlinico G . Martino, Messina Italy

Collaborator

Azienda Ospedaliera Universitaria Senese

Collaborator

Azienda Sanitaria di Firenze

Collaborator

Ospedale San Luca, Istituto Auxologico Italiano, Milano

Collaborator

Casa di Cura Mater Dei

Collaborator

University of Bari

Collaborator

Azienda Ospedaliera di Perugia

Collaborator

I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy

Collaborator

IRCCS Multimedica

Collaborator

Ospedali Riuniti Ancona

Collaborator

A.O. Ospedale Papa Giovanni XXIII

Collaborator

S. Andrea Hospital

Collaborator

Istituti Clinici Scientifici Maugeri SpA

Collaborator

Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano

Collaborator

Azienda Ospedaliero-Universitaria Senese

Collaborator

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Collaborator

Federico II University

Collaborator

Ospedale Guglielmo da Saliceto, Piacenza

Collaborator