Actively Recruiting

Age: 18Years +
All Genders
NCT06884631

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

Led by Centro Cardiologico Monzino · Updated on 2025-03-19

10000

Participants Needed

26

Research Sites

411 weeks

Total Duration

On this page

Sponsors

C

Centro Cardiologico Monzino

Lead Sponsor

S

Santo Spirito Hospital, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Past or present diagnosis of heart failure with NYHA functional class I to III and stage C ACC/AHA classification
  • Documented left ventricular systolic dysfunction with ejection fraction below 40%
  • Stable clinical condition
  • Previous or current cardiopulmonary exercise test (CPET) performed
Not Eligible

You will not qualify if you...

  • Scheduled cardiovascular treatment
  • Clinically unstable condition
  • History of pulmonary embolism
  • Significant valvular disease
  • Pericardial disease
  • Severe chronic obstructive pulmonary disease (COPD)
  • Exercise-induced angina or ECG changes
  • Severe slow or fast heart rhythm disturbances
  • Comorbidities interfering with exercise performance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

Centro Cardiologico Monzino

Milan, Italy, Italy, 20138

Actively Recruiting

2

Ospedali Riuniti di Ancona

Ancona, Italy

Actively Recruiting

3

Istituti Clinici Scientifici Maugeri Bari

Bari, Italy

Actively Recruiting

4

Ospedale papa Giovanni XXIII

Bergamo, Italy

Actively Recruiting

5

Spedali Civili Brescia

Brescia, Italy

Not Yet Recruiting

6

Spedali Civili

Brescia, Italy

Actively Recruiting

7

Università di Foggia

Foggia, Italy

Actively Recruiting

8

I.R.C.C.S. Ospedale San Raffaele

Milan, Italy

Actively Recruiting

9

IRCCS Istituto Auxologico Italiano

Milan, Italy

Actively Recruiting

10

IRCCS Multimedica- Ospedale San Giuseppe

Milan, Italy

Actively Recruiting

11

Istituti Clinici Scientifici Maugeri Milano

Milan, Italy

Not Yet Recruiting

12

Ospedale Cà Granda- A.O. Niguarda

Milan, Italy

Not Yet Recruiting

13

Azienda Ospedaliera dei Colli - Ospedale Monaldi

Naples, Italy

Actively Recruiting

14

Federico II hospital

Naples, Italy

Actively Recruiting

15

Università degli Studi di Napoli Federico II

Naples, Italy

Actively Recruiting

16

Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione

Palermo, Italy

Not Yet Recruiting

17

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Actively Recruiting

18

Fondazione Gabriele Monasterio

Pisa, Italy

Actively Recruiting

19

Azienda Ospedaliera San Camillo-Forlanini

Roma, Italy

Actively Recruiting

20

Azienda Ospedaliera Sant'Andrea

Roma, Italy

Actively Recruiting

21

Azienda Ospedaliero-Universitaria Policinico Umberto I

Rome, Italy

Not Yet Recruiting

22

Santo Spirito Hospital

Rome, Italy

Actively Recruiting

23

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Actively Recruiting

24

S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC)

Siena, Italy

Not Yet Recruiting

25

S. Maria alle Scotte Hospital UOSA malattie cardiovascolari

Siena, Italy

Not Yet Recruiting

26

Azienda sanitaria universitaria Giuliano Isontina (ASUGI)

Trieste, Italy

Actively Recruiting

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Research Team

P

Piergiuseppe Agostoni, Professor

CONTACT

E

Elisabetta Salvioni, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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