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

HF - Heart Failure Clinical Trial

— MECKI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070519
• Other study ID #: CCM1827
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: October 2023
• Source: Centro Cardiologico Monzino
• Contact: Piergiuseppe Agostoni, Prof
• Phone: 02 58002586
• Email: piergiuseppe.agostoni[@]cardiologicomonzino.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• HF - Heart Failure

Intervention

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)

Locations

Country	Name	City	State
Italy	IRCCS Centro Cardiologico Monzino	Milano	Milan
Italy	Università di Napoli Federico II	Napoli
Italy	Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione	Palermo
Italy	Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica	Pisa

Sponsors (4)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino	Federico II University, Fondazione Toscana Gabriele Monasterio, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. Erratum In: Eur Heart J. 2021 Oct 14;: — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day-by-day variability of MECKI score	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
Primary	Identification of interobserver variability	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	Time-related dynamic changes of peak oxygen intake (VO2)	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
Secondary	Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope	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
Secondary	Time-related dynamic changes of MDRD	Modifications of MDRD in 6-12-18-24 months will be evaluated in relation to prognosis	through study completion, an average of 3 year
Secondary	Time-related dynamic changes of LVEF	Modifications of LVEF in 6-12-18-24 months will be evaluated in relation to prognosis	through study completion, an average of 3 year
Secondary	Time-related dynamic changes of hemoglobin	Modifications of hemoglobin in 6-12-18-24 months will be evaluated in relation to prognosis	through study completion, an average of 3 year
Secondary	Time-related dynamic changes of Na+	Modifications of Na+ in 6-12-18-24 months will be evaluated in relation to prognosis	through study completion, an average of 3 year
Secondary	The identification of the prognostic meaning of MECKI score changes at 6 months	Modifications of MECKI score at 6 months will be evaluated in relation to prognosis	6 months
Secondary	The identification of the prognostic meaning of MECKI score changes at one year	Modifications of MECKI score at one year will be evaluated in relation to prognosis	one year