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Taking people in ItalyNo phase

Refining a Risk Score for Heart Failure Patients Using Exercise Testing

Studies an updated MECKI risk score in adults with heart failure, using exercise test results.

Plain-language title generated from the registry record
Registry title: Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure

Key facts

Where
Ancona, Bari, Bergamo, Brescia, Foggia, Milan, Naples, Palermo, Piacenza, Pisa, Roma, Rome, San Donato Milanese, Siena, and Trieste, ItalySee the 26 sites

Where in Italy

  • Ospedali Riuniti di AnconaAncona, ItalyTaking people
  • Istituti Clinici Scientifici Maugeri BariBari, ItalyTaking people
  • Ospedale Papa Giovanni XXIIIBergamo, ItalyTaking people
  • Spedali CiviliBrescia, ItalyTaking people
  • Spedali Civili BresciaBrescia, ItalyNot yet recruiting
  • Università di FoggiaFoggia, ItalyTaking people
  • Centro Cardiologico MonzinoMilan, ItalyTaking people
  • I.R.C.C.S. Ospedale San RaffaeleMilan, ItalyTaking people
  • IRCCS Istituto Auxologico ItalianoMilan, ItalyTaking people
  • IRCCS Multimedica- Ospedale San GiuseppeMilan, ItalyTaking people
  • Istituti Clinici Scientifici Maugeri MilanoMilan, ItalyNot yet recruiting
  • Ospedale Cà Granda- A.O. NiguardaMilan, ItalyNot yet recruiting
  • Azienda Ospedaliera Dei Colli Ospedale MonaldiNaples, ItalyTaking people
  • Federico II hospitalNaples, ItalyTaking people
  • Università degli studi di Napoli Federico IINaples, ItalyTaking people
  • Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazionePalermo, ItalyNot yet recruiting
  • Ospedale Guglielmo da SalicetoPiacenza, ItalyTaking people
  • Fondazione Gabriele MonasterioPisa, ItalyTaking people
  • Azienda Ospedaliera San Camillo ForlaniniRoma, ItalyTaking people
  • Azienda Ospedaliera Sant AndreaRoma, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policinico Umberto IRome, ItalyNot yet recruiting
  • Santo Spirito HospitalRome, ItalyTaking people
  • IRCCS Policlinico San DonatoSan Donato Milanese, ItalyTaking people
  • S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC)Siena, ItalyNot yet recruiting
  • S. Maria alle Scotte Hospital UOSA malattie cardiovascolariSiena, ItalyNot yet recruiting
  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)Trieste, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Centro Cardiologico Monzino
Trial code
NCT06884631
Record updated
19 March 2025
Original description
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.Read full original descriptionShow less

Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure

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.

Inclusion: 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: 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; scheduled cardiovascular treatment.

ClinicalTrials.gov NCT06884631