NCT06070519

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 2, 2023

Last Update Submit

October 2, 2023

Conditions

HF - Heart Failure

Keywords

Cardiopulmonary exercise testing- CPETMetabolic Exercise Cardiac Kidney Indexes (MECKI) score

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Time-related dynamic changes of peak oxygen intake (VO2)

    through study completion, an average of 3 year

  • Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope

    through study completion, an average of 3 year

  • Time-related dynamic changes of MDRD

    through study completion, an average of 3 year

  • Time-related dynamic changes of LVEF

    through study completion, an average of 3 year

  • Time-related dynamic changes of hemoglobin

    through study completion, an average of 3 year

  • +3 more secondary outcomes

Study Arms (1)

Sigle arm study

EXPERIMENTAL

HF patients who meets all the inclusion and none of the exclusion criteria

Diagnostic Test: CPET and related variables evaluation

Interventions

CPET and related variables evaluationDIAGNOSTIC_TEST

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)

Sigle arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

IRCCS Centro Cardiologico Monzino

Milan, Milan, 20138, Italy

RECRUITING

Università di Napoli Federico II

Napoli, 80138, Italy

RECRUITING

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

Palermo, 90127, Italy

NOT YET RECRUITING

Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica

Pisa, 56124, Italy

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34447992BACKGROUND

  • 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.

    PMID: 22795401BACKGROUND

  • 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.

    PMID: 28949086BACKGROUND

  • 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.

    PMID: 30632680BACKGROUND

  • 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.

    PMID: 33238744BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Piergiuseppe Agostoni, Prof

    IRCCS Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piergiuseppe Agostoni, Prof

CONTACT

02 58002586piergiuseppe.agostoni@cardiologicomonzino.it

Elisabetta Salvioni, PhD

CONTACT

0258002010elisabetta.salvioni@cardiologicomonzino.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 6, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2026

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

IT(4)