Identifying cardiovascular risk in heart failure patients using exercise test data
Official title: Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure
Run by Centro Cardiologico Monzino · NCT06884631 · Data updated 2026-11-12
This study is trying to see if using exercise test data can help identify heart failure patients at higher risk for cardiovascular problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Locations | 26 sites (Milan, Italy and 25 other locations) |
| Status | Recruiting |
| Started | February 10, 2021 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | March 19, 2025 |
| Trial ID | NCT06884631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old with a history of heart failure and documented left ventricular systolic dysfunction.
✕Probably not a fit
Patients with unstable clinical conditions or significant comorbidities that interfere with exercise performance may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enhance the assessment of cardiovascular risk in patients with heart failure by utilizing the MECKI score, which integrates data from cardiopulmonary exercise testing (CPET) along with cardiac and kidney indexes. The study focuses on patients with left ventricular systolic dysfunction and stable clinical conditions, aiming to identify high-risk individuals through a comprehensive analysis of multiple prognostic factors. By incorporating ventilatory parameters and renal function into existing risk models, the study seeks to provide a more accurate risk estimation for heart failure patients.
Why it matters
Potential benefit: If successful, this approach could lead to improved risk stratification and management of heart failure patients, potentially enhancing patient outcomes.
How similar studies have gone: Previous studies have shown promise in using combined prognostic models in heart failure, but the specific integration of the MECKI score represents a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Centro Cardiologico Monzino
Milan, Italy, 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, Italy Recruiting -
Università di Foggia
Foggia, Italy Recruiting
Show 20 more locations
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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 -
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 -
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 -
Santo Spirito Hospital
Rome, Italy Recruiting -
IRCCS Policlinico San Donato
San Donato Milanese, Italy Recruiting -
Azienda sanitaria universitaria Giuliano Isontina (ASUGI)
Trieste, Italy Recruiting -
Spedali Civili Brescia
Brescia, Italy Not yet recruiting -
Istituti Clinici Scientifici Maugeri Milano
Milan, Italy Not yet recruiting -
Ospedale Cà Granda- A.O. Niguarda
Milan, Italy Not yet recruiting -
Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
Palermo, Italy Not yet recruiting -
Azienda Ospedaliero-Universitaria Policinico Umberto I
Rome, Italy Not yet 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
Study contacts
- Study coordinator: Piergiuseppe Agostoni, Professor
- Email: piergiuseppe.agostoni@ccfm.it
- Phone: +390258002010
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.