RecruitingNot ApplicableNCT06070519

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

Sponsor

Centro Cardiologico Monzino

Enrollment

400 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

HF - Heart Failure

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the MECKI Score — a tool that uses exercise testing and other measurements to predict outcomes for people living with chronic heart failure. Researchers want to see how well this scoring system can guide treatment decisions over time. **You may be eligible if...** - You have been diagnosed with chronic heart failure (any symptom level) - Your heart's pumping function (ejection fraction) is below 40% - Your heart failure medications have been stable for at least three months - You are able to complete a cardiopulmonary exercise test (a supervised exercise test while breathing is monitored) **You may NOT be eligible if...** - You have had a pulmonary embolism (blood clot in the lungs) - You have moderate to severe valve disease (aortic or mitral stenosis) - You have pericardial disease or severe lung disease - You have a major heart procedure planned in the near future Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCPET and related variables evaluation

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, it will be performed: * Echocardiography (LVEF) * Blood sample (Na+, MDRD, Hb) * Maximal ramp protocol CPET (peakVO2, VE/VCO2 slope)

Locations(4)

IRCCS Centro Cardiologico Monzino

Milan, Milan, Italy

Università di Napoli Federico II

Naples, Italy

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, Italy

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

Pisa, Italy

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NCT06070519

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