Actively Recruiting
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
Eligibility Criteria
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
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
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
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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