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

October 2, 2023 updated by: Centro Cardiologico Monzino

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Napoli, Italy, 80138
        • Recruiting
        • Università di Napoli Federico II
        • Contact:
      • Palermo, Italy, 90127
        • Not yet recruiting
        • Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
        • Contact:
      • Pisa, Italy, 56124
        • Recruiting
        • Fondazione Toscana Gabriele Monasterio per la Ricerca Medica e di Sanita Pubblica
        • Contact:
    • Milan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sigle arm study
HF patients who meets all the inclusion and none of the exclusion criteria
Diagnostic test: CPET 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Day-by-day variability of MECKI score
Time Frame: 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.
through study completion, an average of 3 year
Identification of interobserver variability
Time Frame: 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
through study completion, an average of 3 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Federico II University
Fondazione Toscana Gabriele Monasterio
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Investigators

  • Principal Investigator: Piergiuseppe Agostoni, Prof, IRCCS Centro Cardiologico Monzino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCM1827

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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