Identifying cardiovascular risk in heart failure patients using exercise test data
Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure
Centro Cardiologico Monzino · NCT06884631
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 |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino (other) |
| Locations | 26 sites (Milan, Italy and 25 other locations) |
| Trial ID | NCT06884631 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unstable clinical conditions or significant comorbidities that interfere with exercise performance may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Italy and 25 other locations
- 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 — 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)
Study contacts
- Study coordinator: Piergiuseppe Agostoni, Professor
- Email: piergiuseppe.agostoni@ccfm.it
- Phone: +390258002010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, prognosis, risk score, heart failure, cardiopulmonary exercise test, exercise