A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score

Last updated: October 2, 2023
Sponsor: Centro Cardiologico Monzino
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Congestive Heart Failure

Chest Pain

Treatment

CPET and related variables evaluation

Clinical Study ID

NCT06070519
CCM1827
  • Ages > 18
  • All Genders

Study Summary

The project is dedicated to the improvement of our capability to provide a precise and personalized prognosis in heart failure (HF) patients in stable conditions. The Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score is one of the 3 HF prognostic models recommended by the 2021 European HF guidelines and it is considered the most powerful prognostic tool available. MECKI score integrates cardiopulmonary exercise test (CPET) data with easy-to-obtain clinical, laboratory, and echocardiographic variables. It is based on 6 parameters: peak oxygen intake (peakVO2), minute ventilation/carbon dioxide production (VE/VCO2 slope), hemoglobin (Hb), Left Ventricle Ejection Fraction (LVEF), kidney function by Modification of Diet in Renal Disease (MDRD) formula, and sodium (Na+).

The aim of the present project is to assess the day-by-day MECKI score variability, CPET parameters interobserver variability, characterization of HF patients who change MECKI score values in 6 and 12 months, and the prognostic meaning of time dependent MECKI score changes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Previous or present HF symptoms (NYHA functional class I-IV, stage B and C of ACC/AHAclassification)
  • history or presence of left ventricular ejection fraction (LVEF)<40%
  • unchanged HF medications for at least three months
  • ability to perform a CPET
  • no major cardiovascular treatment or intervention scheduled

Exclusion

Exclusion Criteria:

  • History of pulmonary embolism
  • moderate-to-severe aortic and mitral stenosis
  • pericardial disease
  • severe obstructive lung disease
  • exercise-induced angina
  • significant ECG alterations, or presence of any clinical comorbidity interfering withexercise performance

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: CPET and related variables evaluation
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 01, 2026

Study Description

This is a low-intervention multicenter clinical trial aim at evaluating the role of time dependent prognostic parameters changes, moving from the single shot evaluation to dynamic analysis. Each participant center will perform patients' recruitment and follow up. At the baseline visit, CPET-related variables, echocardiographic, ECG, therapy and blood chemistry data will be collected. The baseline CPET will be repeated within 2 weeks. Patients will perform 4 follow up visits at 6, 12, 18 and 24 months after the baseline visit. At every study step, study procedures aimed to calculate MECKI score will be performed:

  • Echocardiography (Left Ventricle Ejection Fraction - LVEF)

  • Blood sample (Na+, MDRD, Hb)

  • Maximal ramp protocol CPET (peakVO2, minute ventilation/carbon dioxide production (VE/VCO2) slope - VE/VCO2 slope)

Connect with a study center

  • IRCCS Centro Cardiologico Monzino

    Milano, Milan 20138
    Italy

    Active - Recruiting

  • Università di Napoli Federico II

    Napoli, 80138
    Italy

    Active - Recruiting

  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

    Palermo, 90127
    Italy

    Site Not Available

  • Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica

    Pisa, 56124
    Italy

    Active - Recruiting

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