NCT06884631Recruiting
Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure
Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure
Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 10 Mar 2025
- Start date
- 10 Feb 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Centro Cardiologico Monzino
- Diseases
- Heart failure
- NCT number
- NCT06884631
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 10 Feb 2021 to the primary completion date, 31 Dec 2026
- 26 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- scheduled cardiovascular treatment
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedali Riuniti di Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| Istituti Clinici Scientifici Maugeri Bari Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Ospedale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Spedali Civili Coordinator of this site? Confirm its status | Brescia | Italy | Recruiting |
| Spedali Civili Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Not yet recruiting |
| Università di Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Recruiting |
| I.R.C.C.S. Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituto Auxologico Italiano Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituti Clinici Scientifici Maugeri Milano Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale Cà Granda- A.O. Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| IRCCS Multimedica- Ospedale San Giuseppe Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Federico II hospital Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera Dei Colli Ospedale Monaldi Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Università degli studi di Napoli Federico II Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione Coordinator of this site? Confirm its status | Palermo | Italy | Not yet recruiting |
| Ospedale Guglielmo da Saliceto Coordinator of this site? Confirm its status | Piacenza | Italy | Recruiting |
| Fondazione Gabriele Monasterio Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Azienda Ospedaliera San Camillo Forlanini Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Azienda Ospedaliera Sant Andrea Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Santo Spirito Hospital Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| IRCCS Policlinico San Donato Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Recruiting |
| S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC) Coordinator of this site? Confirm its status | Siena | Italy | Not yet recruiting |
| S. Maria alle Scotte Hospital UOSA malattie cardiovascolari Coordinator of this site? Confirm its status | Siena | Italy | Not yet recruiting |
| Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) Coordinator of this site? Confirm its status | Trieste | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.