Clinical trial NCT06070519: A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
Official title: A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HF - Heart Failure
Keywords: Cardiopulmonary exercise testing- CPET
Metabolic Exercise Cardiac Kidney Indexes (MECKI) score
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Federico II University
name: Fondazione Toscana Gabriele Monasterio
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
First posted: 2023-10-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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)

Eligibility criteria: 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

Primary outcomes:
measure: Day-by-day variability of MECKI score
timeFrame: through study completion, an average of 3 year
measure: Identification of interobserver variability
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
measure: Time-related dynamic changes of peak oxygen intake (VO2)
timeFrame: through study completion, an average of 3 year
measure: Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope
timeFrame: through study completion, an average of 3 year
measure: Time-related dynamic changes of MDRD
timeFrame: through study completion, an average of 3 year
measure: Time-related dynamic changes of LVEF
timeFrame: through study completion, an average of 3 year
measure: Time-related dynamic changes of hemoglobin
timeFrame: through study completion, an average of 3 year
measure: Time-related dynamic changes of Na+
timeFrame: through study completion, an average of 3 year
measure: The identification of the prognostic meaning of MECKI score changes at 6 months
timeFrame: 6 months
measure: The identification of the prognostic meaning of MECKI score changes at one year
timeFrame: one year
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Centro Cardiologico Monzino
state: Milan
city: Napoli
country: Italy
facility: Università di Napoli Federico II
city: Palermo
country: Italy
facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
city: Pisa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica
Study officials:
affiliation: IRCCS Centro Cardiologico Monzino
name: Piergiuseppe Agostoni, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
citation: Agostoni P, Corra U, Cattadori G, Veglia F, La Gioia R, Scardovi AB, Emdin M, Metra M, Sinagra G, Limongelli G, Raimondo R, Re F, Guazzi M, Belardinelli R, Parati G, Magri D, Fiorentini C, Mezzani A, Salvioni E, Scrutinio D, Ricci R, Bettari L, Di Lenarda A, Pastormerlo LE, Pacileo G, Vaninetti R, Apostolo A, Iorio A, Paolillo S, Palermo P, Contini M, Confalonieri M, Giannuzzi P, Passantino A, Cas LD, Piepoli MF, Passino C; MECKI Score Research Group. Metabolic exercise test data combined with cardiac and kidney indexes, the MECKI score: a multiparametric approach to heart failure prognosis. Int J Cardiol. 2013 Sep 10;167(6):2710-8. doi: 10.1016/j.ijcard.2012.06.113. Epub 2012 Jul 15.
citation: Agostoni P, Paolillo S, Mapelli M, Gentile P, Salvioni E, Veglia F, Bonomi A, Corra U, Lagioia R, Limongelli G, Sinagra G, Cattadori G, Scardovi AB, Metra M, Carubelli V, Scrutinio D, Raimondo R, Emdin M, Piepoli M, Magri D, Parati G, Caravita S, Re F, Cicoira M, Mina C, Correale M, Frigerio M, Bussotti M, Oliva F, Battaia E, Belardinelli R, Mezzani A, Pastormerlo L, Guazzi M, Badagliacca R, Di Lenarda A, Passino C, Sciomer S, Zambon E, Pacileo G, Ricci R, Apostolo A, Palermo P, Contini M, Clemenza F, Marchese G, Gargiulo P, Binno S, Lombardi C, Passantino A, Filardi PP. Multiparametric prognostic scores in chronic heart failure with reduced ejection fraction: a long-term comparison. Eur J Heart Fail. 2018 Apr;20(4):700-710. doi: 10.1002/ejhf.989. Epub 2017 Sep 26.
citation: Paolillo S, Veglia F, Salvioni E, Corra U, Piepoli M, Lagioia R, Limongelli G, Sinagra G, Cattadori G, Scardovi AB, Metra M, Senni M, Bonomi A, Scrutinio D, Raimondo R, Emdin M, Magri D, Parati G, Re F, Cicoira M, Mina C, Correale M, Frigerio M, Bussotti M, Battaia E, Guazzi M, Badagliacca R, Di Lenarda A, Maggioni A, Passino C, Sciomer S, Pacileo G, Mapelli M, Vignati C, Clemenza F, Binno S, Lombardi C, Filardi PP, Agostoni P; MECKI Score Research Group (see Appendix). Heart failure prognosis over time: how the prognostic role of oxygen consumption and ventilatory efficiency during exercise has changed in the last 20 years. Eur J Heart Fail. 2019 Feb;21(2):208-217. doi: 10.1002/ejhf.1364. Epub 2019 Jan 11.
citation: Salvioni E, Bonomi A, Re F, Mapelli M, Mattavelli I, Vitale G, Sarullo FM, Palermo P, Veglia F, Agostoni P. The MECKI score initiative: Development and state of the art. Eur J Prev Cardiol. 2020 Dec;27(2_suppl):5-11. doi: 10.1177/2047487320959010.