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

Centro Cardiologico Monzino

Status: Enrolling

Conditions: HF - Heart Failure

Treatments: Diagnostic Test: CPET and related variables evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT06070519

CCM1827

Details and patient eligibility

About

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.

Full 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)

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous or present HF symptoms (NYHA functional class I-IV, stage B and C of ACC/AHA classification)
• 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 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 with exercise performance

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Sigle arm study

Experimental group

Description:

HF patients who meets all the inclusion and none of the exclusion criteria

Treatment:

Diagnostic Test: CPET and related variables evaluation