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

Not Applicable

Recruiting

• Conditions: HF - Heart Failure
• Interventions: Diagnostic Test: CPET and related variables evaluation

• Registration Number: NCT06070519
• Lead Sponsor: Centro Cardiologico Monzino

Brief 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.

Detailed 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)

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-02
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sigle arm study	CPET and related variables evaluation	HF patients who meets all the inclusion and none of the exclusion criteria

Primary Outcome Measures

Name	Time	Method
Day-by-day variability of MECKI score	through study completion, an average of 3 year	Day by day variability of MECKI score will be done by comparing MECKI score value obtained at study run-in (day 0) and in a second evaluation of MECKI score performed within 2 weeks.
Identification of interobserver variability	through study completion, an average of 3 year	CPET interobservers variability will be done by assessing CPET analysis done by two recognized CPET experts blinded on patients data

Secondary Outcome Measures

Name	Time	Method
Time-related dynamic changes of hemoglobin	through study completion, an average of 3 year	Modifications of hemoglobin in 6-12-18-24 months will be evaluated in relation to prognosis
Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope	through study completion, an average of 3 year	Modifications in minute ventilation/carbon dioxide production (VE/VCO2) slope in 6-12-18-24 months will be evaluated in relation to prognosis
The identification of the prognostic meaning of MECKI score changes at 6 months	6 months	Modifications of MECKI score at 6 months will be evaluated in relation to prognosis
Time-related dynamic changes of MDRD	through study completion, an average of 3 year	Modifications of MDRD in 6-12-18-24 months will be evaluated in relation to prognosis
The identification of the prognostic meaning of MECKI score changes at one year	one year	Modifications of MECKI score at one year will be evaluated in relation to prognosis
Time-related dynamic changes of peak oxygen intake (VO2)	through study completion, an average of 3 year	Modifications in peak oxygen intake (VO2) in 6-12-18-24 months will be evaluated in relation to prognosis
Time-related dynamic changes of LVEF	through study completion, an average of 3 year	Modifications of LVEF in 6-12-18-24 months will be evaluated in relation to prognosis
Time-related dynamic changes of Na+	through study completion, an average of 3 year	Modifications of Na+ in 6-12-18-24 months will be evaluated in relation to prognosis

Trial Locations

Locations (4)

Università di Napoli Federico II; 🇮🇹 Napoli, Italy

IRCCS Centro Cardiologico Monzino; 🇮🇹 Milano, Milan, Italy

Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica; 🇮🇹 Pisa, Italy

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione; 🇮🇹 Palermo, Italy