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Clinical Trials in Italy / NCT06884631
Recruiting Observational

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

NCT06884631 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-02-10
Last updated
2025-03-19

Condition(s) studied

Heart Failure

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Centro Cardiologico Monzino Milan Italy Recruiting
Ospedali Riuniti di Ancona Ancona Italy Recruiting
Istituti Clinici Scientifici Maugeri Bari Bari Italy Recruiting
Ospedale papa Giovanni XXIII Bergamo Italy Recruiting
Spedali Civili Brescia Brescia Italy Not Yet Recruiting
Spedali Civili Brescia Italy Recruiting
Università di Foggia Foggia Italy Recruiting
I.R.C.C.S. Ospedale San Raffaele Milan Italy Recruiting
IRCCS Istituto Auxologico Italiano Milan Italy Recruiting
IRCCS Multimedica- Ospedale San Giuseppe Milan Italy Recruiting
Istituti Clinici Scientifici Maugeri Milano Milan Italy Not Yet Recruiting
Ospedale Cà Granda- A.O. Niguarda Milan Italy Not Yet Recruiting
Azienda Ospedaliera dei Colli - Ospedale Monaldi Naples Italy Recruiting
Federico II hospital Naples Italy Recruiting
Università degli Studi di Napoli Federico II Naples Italy Recruiting
Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione Palermo Italy Not Yet Recruiting
Ospedale Guglielmo da Saliceto Piacenza Italy Recruiting
Fondazione Gabriele Monasterio Pisa Italy Recruiting
Azienda Ospedaliera San Camillo-Forlanini Roma Italy Recruiting
Azienda Ospedaliera Sant'Andrea Roma Italy Recruiting
Azienda Ospedaliero-Universitaria Policinico Umberto I Rome Italy Not Yet Recruiting
Santo Spirito Hospital Rome Italy Recruiting
IRCCS Policlinico San Donato San Donato Milanese Italy Recruiting
S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC) Siena Italy Not Yet Recruiting
S. Maria alle Scotte Hospital UOSA malattie cardiovascolari Siena Italy Not Yet Recruiting
Azienda sanitaria universitaria Giuliano Isontina (ASUGI) Trieste Italy Recruiting

More Centro Cardiologico Monzino trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06884631 on ClinicalTrials.gov ↗ ← All trials in Italy