Heart FailureMECKINCT06884631
Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Identification of Cardiovascular Risk in Patients with Heart Failure
An observational study of Heart Failure, run by Centro Cardiologico Monzino at 26 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 10,000 participants
- Where
- 26 sitesItaly
- Study dates
- 10 Feb 2021to 31 Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
Italy26 sites, 26 recruiting
- Recruiting
Ospedali Riuniti di Ancona
Ancona
Maria Vittoria Matassini, 000, mavimatassini@gmail.com
- Recruiting
Istituti Clinici Scientifici Maugeri Bari
Bari
Andrea Passantino, 00000, andrea.passantino@icsmaugeri.it
- Recruiting
Ospedale papa Giovanni XXIII
Bergamo
Annamaria Iorio, 0000, anita.iorio@hotmail.it
- Not yet recruiting
Spedali Civili Brescia
Brescia
Savina Nodari, 0000, studi.clinici@asst-spedalicivili.it
- Recruiting
Spedali Civili
Brescia
Marco Metra, 000000, studi.clinici@asst-spedalicivili.it
- Recruiting
Università di Foggia
Foggia
Michele Correale, 000000, michele.correale@libero.it
- Recruiting
Centro Cardiologico Monzino
Milan, Italy, 20138
Piergiuseppe Agostoni, +390258002010, elisabetta.salvioni@ccfm.it
- Recruiting
I.R.C.C.S. Ospedale San Raffaele
Milan
Rosa Raimondo, 00000, RAIMONDO.ROSA@hsr.it
- Recruiting
IRCCS Istituto Auxologico Italiano
Milan
Gianfranco Parati, 00000, trials@auxologico.it
- Recruiting
IRCCS Multimedica- Ospedale San Giuseppe
Milan
Gaia Cattadori, 00000, gaia.cattadori@multimedica.it
- Not yet recruiting
Istituti Clinici Scientifici Maugeri Milano
Milan
Maurizio Bussotti, 000, maurizio.bussotti@icsmaugeri.it
- Not yet recruiting
Ospedale Cà Granda- A.O. Niguarda
Milan
Enrico Perna, 00000, enrico.perna@ospedaleniguarda.it
- Recruiting
Azienda Ospedaliera dei Colli - Ospedale Monaldi
Naples
Giuseppe Limongelli, 000000, limongelligiuseppe@libero.it
- Recruiting
Federico II hospital
Naples
Antonio Cittadini, 0000, antonio.cittadini@unina.it
- Recruiting
Università degli Studi di Napoli Federico II
Naples
Pasquale Perrone Filardi, 0000, paolilloste@gmail.com
- Not yet recruiting
Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione
Palermo
- Recruiting
Ospedale Guglielmo da Saliceto
Piacenza
Francesco Di Spigno, 00000, F.DiSpigno@ausl.pc.it
- Recruiting
Fondazione Gabriele Monasterio
Pisa
Michele Emdin, 0000, emdin@ftgm.it
- Recruiting
Azienda Ospedaliera San Camillo-Forlanini
Roma
Federica Re, 0000, federica.re@sancamilloforlanini.rm.it
- Recruiting
Azienda Ospedaliera Sant'Andrea
Roma
Damiano Magrì, 0000, damiano.magri@uniroma1.it
- Not yet recruiting
Azienda Ospedaliero-Universitaria Policinico Umberto I
Rome
- Recruiting
Santo Spirito Hospital
Rome
Angela B Scardovi, 00000, angela.scardovi@aslroma1.it
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese
Massimo Piepoli, 0000, massimo.piepoli@unimi.it
- Not yet recruiting
S. Maria alle Scotte Hospital UOC cardiologia clinico-chirurgica (UTIC)
Siena
Francesca Righini, 00000, righini.francescamaria@gmail.com
- Not yet recruiting
S. Maria alle Scotte Hospital UOSA malattie cardiovascolari
Siena
Alberto Palazzuoli, 000, palazzuoli2@unisi.it
- Recruiting
Azienda sanitaria universitaria Giuliano Isontina (ASUGI)
Trieste
Gianfranco SInagra, 0000, gianfranco.sinagra@asugi.sanita.fvg.it
About this study
Official title: Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure
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.
Read more
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.
Read the detailed description
Heart failure is a complex condition affecting multiple organs beyond the cardiovascular system, influencing disease progression and prognosis. It has become increasingly evident that accurate risk assessment requires considering multiple variables, as no single parameter alone is sufficient for prognosis.
These findings have led to the identification and study of prognostic parameters that, when combined, allow for a more precise risk estimation and identification of high-risk patients. Various prognostic scores have been developed, utilizing algorithms that integrate multiple variables to estimate an individual's mortality risk. Some scores are based on clinical evaluation and comorbidities, others on laboratory findings, baroreflex sensitivity, heart rate, sleep abnormalities, echocardiographic imaging, or cardiopulmonary exercise testing (CPET), either alone or in combination with other factors.
CPET provides several parameters strongly correlated with prognosis. Since the 1990s, its use-alongside clinical data-has been recommended in heart failure management guidelines. More recently, in addition to peak oxygen consumption, the VE/VCO₂ slope has been recognized as a key prognostic marker, reflecting ventilatory efficiency and ventilation-perfusion mismatch, and has been included in heart transplant assessment criteria.
Current risk models in heart failure often omit important prognostic parameters, such as ventilatory indices from CPET, renal function, and hemoglobin levels. Among the numerous prognostic scores available, only the HF Survival Score (HFSS) and the HF Action Predictive Risk Score Model incorporate exercise-related parameters (peak VO₂ in the former and exercise duration in the latter), yet both neglect ventilatory aspects. Even the widely used Seattle Score does not include exercise-related variables.
In 2012, the researchers 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 just six key variables, making it both practical and effective.
Recent studies indicate the need to review and update the cutoff values and parameters used in prognostic models, as the introduction of new therapies and treatment strategies may significantly impact their predictive power in specific patient populations.
Study Objectives and Purpose The aim of this study is to expand and update the patient dataset to further develop the MECKI score, optimizing its application in patient subgroups and adapting it to new therapies and treatments introduced in clinical practice.
Additionally, the researchers seek to determine whether risk prediction accuracy varies in advanced-stage patients, those with comorbidities, or those receiving different treatments. This could lead to the development of correction factors for the MECKI score, improving its predictive power and applicability across different clinical scenarios.
Study Population Patients with systolic heart failure, consecutively enrolled and followed at multiple Heart Failure Units across Italy.
Patients undergo assessment through medical history collection, physical examination, laboratory tests, ECG, transthoracic echocardiography, and cardiopulmonary exercise testing (CPET).
Follow-up will be conducted according to the protocol of the respective Heart Failure Unit. The follow-up period ends at the last evaluation at the reference center, or upon the patient's death or heart transplantation.
- Conditions
- Heart Failure
- Keywords
- prognosis, risk score, heart failure, cardiopulmonary exercise test, exercise
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure patients | Patients with systolic heart failure, able to exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start10 Feb 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Santo Spirito Hospital, Italy, Fondazione Toscana Gabriele Monasterio, Spedali Civili, University of Brescia, Italy, Monaldi Hospital, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), San Raffaele University Hospital, Italy, University of Foggia, Azienda Ospedaliera Niguarda Cà Granda, Azienda Policlinico Umberto I, Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, Città di Lecce Hospital, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Azienda Ospedaliera Universitaria Senese, Azienda Sanitaria di Firenze, Ospedale San Luca, Istituto Auxologico Italiano, Milano, Casa di Cura Mater Dei, University of Bari, Azienda Ospedaliera di Perugia, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy, IRCCS Multimedica, Ospedali Riuniti Ancona, A.O. Ospedale Papa Giovanni XXIII, S. Andrea Hospital, Istituti Clinici Scientifici Maugeri SpA, Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano, Azienda Ospedaliero-Universitaria Senese, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Federico II University, Ospedale Guglielmo da Saliceto, Piacenza
- Responsible party
- Principal investigator, Piergiuseppe Agostoni, Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884631
- Sponsor's protocol ID
- CCM 04-21PA
- Acronym
- MECKI
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Exercise Test Data Combined with Cardiac and Kidney Indexes (MECKI) Score Evolution: Study of Cardiovascular Risk in Patients with Heart Failure
- ClinicalTrials.gov ID
- NCT06884631
- Acronym / sponsor ID
- MECKI / CCM 04-21PA
- Conditions
- Heart Failure
- Keywords
- prognosis, risk score, heart failure, cardiopulmonary exercise test, exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Santo Spirito Hospital, Italy, Fondazione Toscana Gabriele Monasterio, Spedali Civili, University of Brescia, Italy, Monaldi Hospital, Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI), San Raffaele University Hospital, Italy, University of Foggia, Azienda Ospedaliera Niguarda Cà Granda, Azienda Policlinico Umberto I, Federico II University of Naples, Department of Clinical Medicine and Surgery, Naples, Italy, Città di Lecce Hospital, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Azienda Ospedaliera Universitaria Senese, Azienda Sanitaria di Firenze, Ospedale San Luca, Istituto Auxologico Italiano, Milano, Casa di Cura Mater Dei, University of Bari, Azienda Ospedaliera di Perugia, I.R.C.C.S. Policlinico San Donato, San Donato Milanese, Italy, IRCCS Multimedica, Ospedali Riuniti Ancona, A.O. Ospedale Papa Giovanni XXIII, S. Andrea Hospital, Istituti Clinici Scientifici Maugeri SpA, Istituto Auxologico Italiano - IRCCS - Ospedale San Luca - Milano, Azienda Ospedaliero-Universitaria Senese, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies, Federico II University, Ospedale Guglielmo da Saliceto, Piacenza
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart failure is a complex condition affecting multiple organs beyond the cardiovascular system, influencing disease progression and prognosis. It has become increasingly evident that accurate risk assessment requires considering multiple variables, as no single parameter alone is sufficient for prognosis.
These findings have led to the identification and study of prognostic parameters that, when combined, allow for a more precise risk estimation and identification of high-risk patients. Various prognostic scores have been developed, utilizing algorithms that integrate multiple variables to estimate an individual's mortality risk. Some scores are based on clinical evaluation and comorbidities, others on laboratory findings, baroreflex sensitivity, heart rate, sleep abnormalities, echocardiographic imaging, or cardiopulmonary exercise testing (CPET), either alone or in combination with other factors.
CPET provides several parameters strongly correlated with prognosis. Since the 1990s, its use-alongside clinical data-has been recommended in heart failure management guidelines. More recently, in addition to peak oxygen consumption, the VE/VCO₂ slope has been recognized as a key prognostic marker, reflecting ventilatory efficiency and ventilation-perfusion mismatch, and has been included in heart transplant assessment criteria.
Current risk models in heart failure often omit important prognostic parameters, such as ventilatory indices from CPET, renal function, and hemoglobin levels. Among the numerous prognostic scores available, only the HF Survival Score (HFSS) and the HF Action Predictive Risk Score Model incorporate exercise-related parameters (peak VO₂ in the former and exercise duration in the latter), yet both neglect ventilatory aspects. Even the widely used Seattle Score does not include exercise-related variables.
In 2012, the researchers 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 just six key variables, making it both practical and effective.
Recent studies indicate the need to review and update the cutoff values and parameters used in prognostic models, as the introduction of new therapies and treatment strategies may significantly impact their predictive power in specific patient populations.
Study Objectives and Purpose The aim of this study is to expand and update the patient dataset to further develop the MECKI score, optimizing its application in patient subgroups and adapting it to new therapies and treatments introduced in clinical practice.
Additionally, the researchers seek to determine whether risk prediction accuracy varies in advanced-stage patients, those with comorbidities, or those receiving different treatments. This could lead to the development of correction factors for the MECKI score, improving its predictive power and applicability across different clinical scenarios.
Study Population Patients with systolic heart failure, consecutively enrolled and followed at multiple Heart Failure Units across Italy.
Patients undergo assessment through medical history collection, physical examination, laboratory tests, ECG, transthoracic echocardiography, and cardiopulmonary exercise testing (CPET).
Follow-up will be conducted according to the protocol of the respective Heart Failure Unit. The follow-up period ends at the last evaluation at the reference center, or upon the patient's death or heart transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | – | –Patients with systolic heart failure, able to exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Risk score
Time frame: From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years
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.
End point
Time frame: From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years
Time to Cardiovascular death or LVAD implantation or heart transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Centro Cardiologico Monzino at 26 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piergiuseppe Agostoni, Professor (+390258002010, piergiuseppe.agostoni@ccfm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk score (time frame: From enrollment to endpoint occurence (death, LVAD implantation, heart transplant) within 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.