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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
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

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ospedali Riuniti di Ancona
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AnconaItalyRecruiting
Istituti Clinici Scientifici Maugeri Bari
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BariItalyRecruiting
Ospedale Papa Giovanni XXIII
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BergamoItalyRecruiting
Spedali Civili
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BresciaItalyRecruiting
Spedali Civili Brescia
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BresciaItalyNot yet recruiting
Università di Foggia
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FoggiaItalyRecruiting
I.R.C.C.S. Ospedale San Raffaele
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MilanItalyRecruiting
IRCCS Istituto Auxologico Italiano
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MilanItalyRecruiting
Istituti Clinici Scientifici Maugeri Milano
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MilanItalyNot yet recruiting
Centro Cardiologico Monzino
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MilanItalyRecruiting
Ospedale Cà Granda- A.O. Niguarda
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MilanItalyNot yet recruiting
IRCCS Multimedica- Ospedale San Giuseppe
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MilanItalyRecruiting
Federico II hospital
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NaplesItalyRecruiting
Azienda Ospedaliera Dei Colli Ospedale Monaldi
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NaplesItalyRecruiting
Università degli studi di Napoli Federico II
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NaplesItalyRecruiting
Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
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PalermoItalyNot yet recruiting
Ospedale Guglielmo da Saliceto
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PiacenzaItalyRecruiting
Fondazione Gabriele Monasterio
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PisaItalyRecruiting
Azienda Ospedaliera San Camillo Forlanini
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RomaItalyRecruiting
Azienda Ospedaliera Sant Andrea
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RomaItalyRecruiting
Santo Spirito Hospital
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RomeItalyRecruiting
Azienda Ospedaliero-Universitaria Policinico Umberto I
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RomeItalyNot yet recruiting
IRCCS Policlinico San Donato
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San Donato MilaneseItalyRecruiting
S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC)
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SienaItalyNot yet recruiting
S. Maria alle Scotte Hospital UOSA malattie cardiovascolari
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SienaItalyNot yet recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
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TriesteItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.