NCT06884631

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

26 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 Progress66%
Feb 2021Dec 2028

Study Start

First participant enrolled

February 10, 2021

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

5.9 years

First QC Date

March 10, 2025

Last Update Submit

March 18, 2025

Conditions

Heart Failure

Keywords

prognosisrisk scoreheart failurecardiopulmonary exercise testexercise

Outcome Measures

Primary Outcomes (2)

  • Risk score

    Expand and update the patient dataset to further develop the Metabolic Exercise test data combined with Cardiac and Kidney Indexes (MECKI) score, optimizing its application in specific patient subgroups and aligning it with newly introduced therapies and treatments in clinical practice.

    From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years

  • End point

    Time to Cardiovascular death or LVAD implantation or heart transplant

    From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years

Study Arms (1)

Heart failure patients

Patients with systolic heart failure, able to exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with past or present heart failure (with previous documentation of left ventricular systolic dysfunction (LVEF \<40%)), in stable clinical conditions, who underwent a cardiopulmonary exercise test, with no scheduled cardiovascular treatment.

You may qualify if:

  • 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

You may not qualify if:

  • scheduled cardiovascular treatment
  • clinical unstable condition
  • History of pulmonary embolism, significant valvular disease, pericardial disease, severe COPD, exercise-induced angina, exercise-induced ECG changes, severe brady- or tachyarrhythmias, or the presence of comorbidities that interfere with exercise performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Centro Cardiologico Monzino

Milan, Italy, 20138, Italy

RECRUITING

Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Istituti Clinici Scientifici Maugeri Bari

Bari, Italy

RECRUITING

Ospedale papa Giovanni XXIII

Bergamo, Italy

RECRUITING

Spedali Civili Brescia

Brescia, Italy

NOT YET RECRUITING

Spedali Civili

Brescia, Italy

RECRUITING

Università di Foggia

Foggia, Italy

RECRUITING

I.R.C.C.S. Ospedale San Raffaele

Milan, Italy

RECRUITING

IRCCS Istituto Auxologico Italiano

Milan, Italy

RECRUITING

IRCCS Multimedica- Ospedale San Giuseppe

Milan, Italy

RECRUITING

Istituti Clinici Scientifici Maugeri Milano

Milan, Italy

NOT YET RECRUITING

Ospedale Cà Granda- A.O. Niguarda

Milan, Italy

NOT YET RECRUITING

Federico II hospital

Naples, Italy

RECRUITING

Azienda Ospedaliera dei Colli - Ospedale Monaldi

Napoli, Italy

RECRUITING

Università degli Studi di Napoli Federico II

Napoli, Italy

RECRUITING

Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione

Palermo, Italy

NOT YET RECRUITING

Ospedale Guglielmo da Saliceto

Piacenza, Italy

RECRUITING

Fondazione Gabriele Monasterio

Pisa, Italy

RECRUITING

Azienda Ospedaliera San Camillo-Forlanini

Roma, Italy

RECRUITING

Azienda Ospedaliera Sant'Andrea

Roma, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Policinico Umberto I

Rome, Italy

NOT YET RECRUITING

Santo Spirito Hospital

Rome, Italy

RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, Italy

RECRUITING

S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC)

Siena, Italy

NOT YET RECRUITING

S. Maria alle Scotte Hospital UOSA malattie cardiovascolari

Siena, Italy

NOT YET RECRUITING

Azienda sanitaria universitaria Giuliano Isontina (ASUGI)

Trieste, Italy

RECRUITING

MeSH Terms

Conditions

Heart FailureMotor Activity

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavior

Central Study Contacts

Piergiuseppe Agostoni, Professor

CONTACT

+390258002010piergiuseppe.agostoni@ccfm.it

Elisabetta Salvioni, PhD

CONTACT

+390258002010elisabetta.salvioni@ccfm.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 19, 2025

Study Start

February 10, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

IT(26)