Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure

Status: Recruiting
Location: See all (26) locations...
Study Type: Observational
SUMMARY

Heart failure is a complex condition involving multiple organs beyond the cardiovascular system, all influencing disease progression and prognosis. Accurate risk assessment requires considering multiple variables, as no single parameter alone provides a complete prognostic picture. This has led to the development of prognostic models combining clinical and laboratory parameters. Some of these models incorporate cardiopulmonary exercise testing (CPET), which provides key prognostic indicators. Since the 1990s, CPET has been recommended in heart failure management guidelines due to its strong prognostic value when combined with clinical data. However, existing risk models often exclude important predictors such as ventilatory parameters from CPET (VE/VCO₂), renal function, and hemoglobin levels. To address this gap, in 2012 the investigators developed the MECKI (Metabolic Exercise test data combined with Cardiac and Kidney Indexes) score, integrating oxygen consumption, ventilatory efficiency, and easily accessible biochemical and echocardiographic parameters. Unlike previous models requiring extensive data collection, MECKI is based on only six variables, making it practical and effective. Recent studies suggest the need to update the cutoff values and parameters used for risk stratification, as new therapies and treatment strategies may significantly alter prognostic accuracy in different patient populations. This study aims to expand and refine the MECKI score by updating the patient dataset, optimizing its performance in specific subgroups, and aligning it with emerging therapeutic approaches. Additionally, the investigators will evaluate whether the model's risk accuracy varies in advanced-stage patients, those with comorbidities, or under different treatment regimens. This could lead to correction factors that enhance the score's predictive power across diverse clinical scenarios, further improving its applicability and reliability in heart failure management.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age \>18 past or present heart failure (NYHA functional class I-III, stage C of the ACC/AHA classification)

• documentation of left ventricular systolic dysfunction (LVEF \<40%)

• stable clinical conditions

• previous or concomitant cardiopulmonary exercise test

Locations
Other Locations
Italy
Ospedali Riuniti di Ancona
RECRUITING
Ancona
Istituti Clinici Scientifici Maugeri Bari
RECRUITING
Bari
Ospedale papa Giovanni XXIII
RECRUITING
Bergamo
Spedali Civili
RECRUITING
Brescia
Spedali Civili Brescia
NOT_YET_RECRUITING
Brescia
Università di Foggia
RECRUITING
Foggia
Centro Cardiologico Monzino
RECRUITING
Milan
I.R.C.C.S. Ospedale San Raffaele
RECRUITING
Milan
IRCCS Istituto Auxologico Italiano
RECRUITING
Milan
IRCCS Multimedica- Ospedale San Giuseppe
RECRUITING
Milan
Istituti Clinici Scientifici Maugeri Milano
NOT_YET_RECRUITING
Milan
Ospedale Cà Granda- A.O. Niguarda
NOT_YET_RECRUITING
Milan
Federico II hospital
RECRUITING
Naples
Azienda Ospedaliera dei Colli - Ospedale Monaldi
RECRUITING
Napoli
Università degli Studi di Napoli Federico II
RECRUITING
Napoli
Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
NOT_YET_RECRUITING
Palermo
Ospedale Guglielmo da Saliceto
RECRUITING
Piacenza
Fondazione Gabriele Monasterio
RECRUITING
Pisa
Azienda Ospedaliera San Camillo-Forlanini
RECRUITING
Roma
Azienda Ospedaliera Sant'Andrea
RECRUITING
Roma
Azienda Ospedaliero-Universitaria Policinico Umberto I
NOT_YET_RECRUITING
Rome
Santo Spirito Hospital
RECRUITING
Rome
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC)
NOT_YET_RECRUITING
Siena
S. Maria alle Scotte Hospital UOSA malattie cardiovascolari
NOT_YET_RECRUITING
Siena
Azienda sanitaria universitaria Giuliano Isontina (ASUGI)
RECRUITING
Trieste
Contact Information
Primary
Piergiuseppe Agostoni, Professor
piergiuseppe.agostoni@ccfm.it
+390258002010
Backup
Elisabetta Salvioni, PhD
elisabetta.salvioni@ccfm.it
+390258002010
Time Frame
Start Date: 2021-02-10
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 10000
Treatments
Heart failure patients
Patients with systolic heart failure, able to exercise
Related Therapeutic Areas
Sponsors
Collaborators: Federico II University, Azienda Ospedaliera Universitaria Senese, Azienda Ospedaliero-Universitaria Senese, Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, Azienda Policlinico Umberto I, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, ASST Papa Giovanni XXIII, Bergamo, Italy, University of Bari, Città di Lecce Hospital, S. Andrea Hospital, Monaldi Hospital, IRCCS Multimedica, Ospedale San Luca, Istituto Auxologico Italiano, Milano, Spedali Civili, University of Brescia, Italy, Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano, Santo Spirito Hospital, Italy, Fondazione Toscana Gabriele Monasterio, Casa di Cura Mater Dei, San Raffaele University Hospital, Italy, Azienda Sanitaria di Firenze, Azienda Ospedaliera Niguarda Cà Granda, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy, Azienda Ospedaliera di Perugia, University of Foggia, Ospedale Guglielmo da Saliceto, Piacenza, Policlinico G . Martino, Messina Italy, Ospedali Riuniti Ancona, Istituti Clinici Scientifici Maugeri SpA
Leads: Centro Cardiologico Monzino

This content was sourced from clinicaltrials.gov

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