Clinical trial Recruiting at 19 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment10000 (estimated)
SponsorCentro Cardiologico Monzino
Academic / other
Locations26 sites (Milan, Italy and 25 other locations)
StatusRecruiting
StartedFebruary 10, 2021
Main results expectedDecember 31, 2026
Study endsDecember 31, 2028
Registry record updatedMarch 19, 2025
Trial IDNCT06884631 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.