A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
NCT ID: NCT06070519
Last Updated: 2023-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-05-01
2026-05-01
Brief Summary
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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.
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Detailed Description
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* 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)
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Sigle arm study
HF patients who meets all the inclusion and none of the exclusion criteria
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Federico II University
OTHER
Fondazione Toscana Gabriele Monasterio
OTHER
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
OTHER
Centro Cardiologico Monzino
OTHER
Responsible Party
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Principal Investigators
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Piergiuseppe Agostoni, Prof
Role: PRINCIPAL_INVESTIGATOR
IRCCS Centro Cardiologico Monzino
Locations
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IRCCS Centro Cardiologico Monzino
Milan, 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, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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CCM1827
Identifier Type: -
Identifier Source: org_study_id
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