HF - Heart FailureMECKINCT06070519
A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
A study testing CPET and related variables evaluation in people with HF - Heart Failure, run by Centro Cardiologico Monzino at 4 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HF - Heart Failure
- What is being tested?
- CPET and related variables evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesItaly
- Study dates
- 1 May 2023to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Centro Cardiologico Monzino
Milan, Milan, 20138
Piergiuseppe Agostoni, Prof, 02 58002586, piergiuseppe.agostoni@cardiologicomonzino.it
Elisabetta Salvioni, PhD, 02 58002010, elisabetta.salvioni@cardiologicomonzino.it
- Recruiting
Università di Napoli Federico II
Naples, 80138
Stefania Paolillo, Prof, paolilloste@gmail.com
- Not yet recruiting
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo, 90127
Manlio Cipriani, MD, mcipriani@ismett.edu
- Recruiting
Fondazione Toscana Gabriele Monasterio per la ricerca medica e di sanità pubblica
Pisa, 56124
Michele Emdin, Prof, m.emdin@santannapisa.it
About this study
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.
Read the detailed 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)
- Conditions
- HF - Heart Failure
- Being tested
- CPET and related variables evaluation
- Keywords
- Cardiopulmonary exercise testing- CPET, Metabolic Exercise Cardiac Kidney Indexes (MECKI) score
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Sigle arm study | Experimental | HF patients who meets all the inclusion and none of the exclusion criteria Receives: Diagnostic Test: CPET and related variables evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: through study completion, an average of 3 year
Secondary outcomes (8)
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
Measured: through study completion, an average of 3 year
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
Measured: through study completion, an average of 3 year
Time-related dynamic changes of MDRD
Modifications of MDRD in 6-12-18-24 months will be evaluated in relation to prognosis
Measured: through study completion, an average of 3 year
Time-related dynamic changes of LVEF
Modifications of LVEF in 6-12-18-24 months will be evaluated in relation to prognosis
Measured: through study completion, an average of 3 year
Time-related dynamic changes of hemoglobin
Modifications of hemoglobin in 6-12-18-24 months will be evaluated in relation to prognosis
Measured: through study completion, an average of 3 year
Time-related dynamic changes of Na+
Modifications of Na+ in 6-12-18-24 months will be evaluated in relation to prognosis
Measured: through study completion, an average of 3 year
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
Measured: 6 months
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 May 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HF - 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, Fondazione Toscana Gabriele Monasterio, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Responsible party
- Sponsor
- Investigators
- Piergiuseppe Agostoni, Prof, Principal investigator, IRCCS Centro Cardiologico Monzino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070519
- Sponsor's protocol ID
- CCM1827
- Acronym
- MECKI
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34447992Agostoni 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.
PubMed 22795401Agostoni 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.
PubMed 28949086Paolillo 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.
PubMed 30632680Salvioni 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.
PubMed 33238744
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dynamic Evaluation of Chronic Heart Failure Prognosis: the MECKI Score
- ClinicalTrials.gov ID
- NCT06070519
- Acronym / sponsor ID
- MECKI / CCM1827
- Conditions
- HF - Heart Failure
- Keywords
- Cardiopulmonary exercise testing- CPET, Metabolic Exercise Cardiac Kidney Indexes (MECKI) score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Collaborators
- Federico II University, Fondazione Toscana Gabriele Monasterio, The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 6 Oct 2023 (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.
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.
Detailed 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)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sigle arm study | Experimental | Diagnostic Test: CPET and related variables evaluationHF patients who meets all the inclusion and none of the exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- History of pulmonary embolism
- moderate-to-severe aortic and mitral stenosis
- pericardial disease
- severe obstructive lung disease
- exercise-induced angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPET and related variables evaluationAt 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) | Diagnostic test | Sigle arm study |
Primary outcome
Day-by-day variability of MECKI score
Time frame: through study completion, an average of 3 year
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.
Identification of interobserver variability
Time frame: through study completion, an average of 3 year
CPET interobservers variability will be done by assessing CPET analysis done by two recognized CPET experts blinded on patients data
8 secondary outcomes
Time-related dynamic changes of peak oxygen intake (VO2)
Time frame: through study completion, an average of 3 year
Time-related dynamic changes of minute ventilation/carbon dioxide production (VE/VCO2) slope
Time frame: through study completion, an average of 3 year
Time-related dynamic changes of MDRD
Time frame: through study completion, an average of 3 year
Time-related dynamic changes of LVEF
Time frame: through study completion, an average of 3 year
Time-related dynamic changes of hemoglobin
Time frame: through study completion, an average of 3 year
Time-related dynamic changes of Na+
Time frame: through study completion, an average of 3 year
The identification of the prognostic meaning of MECKI score changes at 6 months
Time frame: 6 months
The identification of the prognostic meaning of MECKI score changes at one year
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 34447992McDonagh 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.
- Background: PubMed 22795401Agostoni 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.
- Background: PubMed 28949086Agostoni 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.
- Background: PubMed 30632680Paolillo 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.
- Background: PubMed 33238744Salvioni 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.
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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. This study is not recruiting at the moment.
Piergiuseppe Agostoni, Prof principal investigator
IRCCS Centro Cardiologico Monzino
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPET and related variables evaluation in people with HF - Heart Failure, run by Centro Cardiologico Monzino at 4 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piergiuseppe Agostoni, Prof (02 58002586, piergiuseppe.agostoni@cardiologicomonzino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day-by-day variability of MECKI score (time frame: through study completion, an average of 3 year). 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?
On the ClinicalTrials.gov record for NCT06070519, which also lists 5 linked publications.
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 6 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.