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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Centro Cardiologico Monzino
RECRUITING
Milan
Università di Napoli Federico II
RECRUITING
Napoli
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
NOT_YET_RECRUITING
Palermo
Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica
RECRUITING
Pisa
Contact Information
Primary
Piergiuseppe Agostoni, Prof
piergiuseppe.agostoni@cardiologicomonzino.it
02 58002586
Backup
Elisabetta Salvioni, PhD
elisabetta.salvioni@cardiologicomonzino.it
0258002010
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2026-05-01
Participants
Target number of participants: 400
Treatments
Experimental: Sigle arm study
HF patients who meets all the inclusion and none of the exclusion criteria
Related Therapeutic Areas
Sponsors
Leads: Centro Cardiologico Monzino
Collaborators: Federico II University, Fondazione Toscana Gabriele Monasterio, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

This content was sourced from clinicaltrials.gov