Wilson's DiseaseNCT07765472
Subclinical Myocardial Dysfunction in Children With Wilson's Disease
An observational study of Wilson's Disease and Myocardial Dysfunction, run by Hebatullah Fawzy at 2 sites in Egypt.
Trial summary
Wilson's disease (WD) is one of the most common metabolic liver diseases in older children. The most frequent clinical presentation is liver disease. However, Wilson's disease (WD) is a multisystem disorder. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Wilson's Disease, Myocardial Dysfunction, Children
- What is being tested?
- Echocardiography, Electrocardiography and N-terminal pro b- type natriuretic peptide
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Oct 2025to 30 Nov 2026
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: They will be divided in to 2 groups: - Group 1: Patients confirmed Wilson's disease. - Group 2: Controls. * Patients group: Patient diagnosed as WD patients, following up in Pediatric Hepatology Clinic in NHTMRI. According to Criteria of diagnosis based on Leipzig scoring system (11,12): Typical clinical symptoms and signs, as: Kayser-Fleischer rings, neurological symptoms, serum ceruloplasmin, Coombs-negative hemolytic anemia. Other tests: Liver biopsy, 24hr urinary Cu, gene analysis.
Who may be able to join
- Confirmed diagnosis of Wilson's disease based on Leipzig scoring criteria (including clinical signs, Kayser-Fleischer rings, low ceruloplasmin, or genetic analysis).
- Age between 4 years and 18 years.
- Written informed consent obtained from parents or legal guardians.
Who cannot join
- Children with clinical evidence of overt heart failure or known congenital heart disease.
- Children suffering from fulminant hepatitis.
- Known co-existing primary liver diseases other than Wilson's disease.
- Presence of syndromic disorders or major congenital anomalies.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of medicine AinShams U
Cairo
National Hepatology and Tropical Research Institute (NHTMRI)
Giza
About this study
Official title: Assessment of Subtle Myocardial Dysfunction in Children With Wilson's Disease: A Case-Control Study
Wilson's disease (WD) is one of the most common metabolic liver diseases in older children. The most frequent clinical presentation is liver disease. However, Wilson's disease (WD) is a multisystem disorder. It is concluded that four modes of cardiac manifestations in Wilson's disease (WD) include arrhythmias, cardiomyopathy, cardiac death, and autonomic dysfunction. Such possible cardiac involvement should be added to the clinical picture of Wilson's disease (WD) involving the hepatic and central nervous system(CNS).
The data on cardiac manifestations in children is very limited and only few adult studies are available.
In this study, the investigators aim to unveil subclinical cardiac dysfunction in children with Wilson's disease with apparently normal cardiac functions by conventional assessment.
Read the detailed description
Wilson's disease (WD) is an autosomal recessive metabolic liver disorder caused by toxic copper accumulation. While hepatic and neurological manifestations are well recognized, copper can also accumulate in cardiac tissue, potentially leading to subtle myocardial changes, arrhythmias, and heart failure. Traditional two-dimensional (2D) echocardiography often appears normal in early stages. This study aims to evaluate early left ventricular (LV) systolic and diastolic dysfunction in pediatric patients with Wilson's disease using speckle tracking echocardiography (STE) and tissue Doppler imaging, and to correlate these findings with serum levels of Pro-Brain Natriuretic Peptide (Pro-BNP) and ceruloplasmin.
- Conditions
- Wilson's Disease, Myocardial Dysfunction, Children, Wilson Disease, Speckle Tracking Echocardiography, Electrocardiographic Changes
- Being tested
- Echocardiography, Electrocardiography, N-terminal pro b- type natriuretic peptide
- Keywords
- WD, pedia, cardiac, childern, LV dysfunction, Wilson, BNP, ceruloplasmin, Speckled tracking, Pro-BNP, STE
- Medical subject headings
- Hepatolenticular Degeneration, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
Also called Echo
a safe, painless test that uses sound waves to create moving pictures of your heart's structure and pumping function.
ElectrocardiographyDevice
Also called ECG
a quick, painless test that records the electrical signals in the heart.
N-terminal pro b- type natriuretic peptideDiagnostic test
Also called pro BNP
a protein made by our heart, examined by peripheral blood sample.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Cases) | Children aged 4-18 years with confirmed Wilson's disease recruited from the Pediatric Hepatology Clinic at the National Hepatology and Tropical Medicine Research Institute (NHTMRI). Receives: Device: Echocardiography; Device: Electrocardiography; Diagnostic Test: N-terminal pro b- type natriuretic peptide | |
| Group 2 (Controls) | Age- and sex-matched control children without chronic liver or cardiac illness recruited from the outpatient clinic. Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Peak Longitudinal Strain (LV-PLS)
Left Ventricular Peak Longitudinal Strain (LV-PLS) assessed by Speckle Tracking Echocardiography (STE) to evaluate subclinical LV systolic dysfunction. Expressed as a negative percentage (%), where a less negative percentage indicates impaired function.
Measured: Baseline (Day 1 , at single cross-sectional evaluation).
Secondary outcomes (4)
Serum Pro-Brain Natriuretic Peptide (Pro-BNP) Level
Quantitative measurement of serum Pro-BNP assessed via ELISA (pg/mL) as a circulating biomarker of cardiac wall stress.
Measured: Baseline (Day 1 , at single cross-sectional evaluation).
Tissue Doppler LV Filling Pressure (E/e' Ratio)
Ratio of early mitral inflow velocity (E) measured by conventional Doppler to early diastolic mitral annular velocity (e') measured by tissue Doppler imaging to evaluate LV diastolic function.
Measured: Baseline (Day 1 , at single cross-sectional evaluation).
Serum Ceruloplasmin Level Correlation
Serum ceruloplasmin levels (mg/dL) measured within 6 months of cardiac evaluation to correlate hepatic copper transport marker levels with cardiac function parameters.
Measured: Baseline (Day 1,at time of cardiac evaluation or within 6 months preceding cardiac evaluation).
Frequency of Electrocardiographic (ECG) Abnormalities
Presence or absence of cardiac electrical abnormalities, including conduction delays, ST-T wave changes, and arrhythmias recorded on standard 12-lead ECG.
Measured: Baseline (Day 1 , at single cross-sectional evaluation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Oct 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Wilson's DiseaseStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebatullah Fawzy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hebatullah Fawzy, Ain Shams University
- Investigators
- Hebatullah I Fawzy, Msc Student, Principal investigator, Faculty of medicine AinShams U,National Hepatology and Tropical Research Institute (NHTMRI)Eman M ElSayed (Assistant Professor of Pediatrics), AssProfessor, Study chair, Faculty of Medicine AinShams UMona AH Khafagy (Lecturer of Pediatrics), Lecturer, Study director, Faculty of Medicine AinShams USara M Osman (Teaching Fellow of Pediatrics), PedFellow, Study director, National Hepatology and Tropical Research Institute (NHTMRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765472
- Sponsor's protocol ID
- Wilson's disease and Heart
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wiernicka A, Dadalski M, Janczyk W, Kaminska D, Naorniakowska M, Husing-Kabar A, Schmidt H, Socha P. Early Onset of Wilson Disease: Diagnostic Challenges. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):555-560. doi: 10.1097/MPG.0000000000001700.
PubMed 28753182European Association for the Study of the Liver. EASL-ERN Clinical Practice Guidelines on Wilson's disease. J Hepatol. 2025 Feb 22:S0168-8278(24)02706-5. doi: 10.1016/j.jhep.2024.11.007. Online ahead of print.
PubMed 40089450European Association for Study of Liver. EASL Clinical Practice Guidelines: Wilson's disease. J Hepatol. 2012 Mar;56(3):671-85. doi: 10.1016/j.jhep.2011.11.007.
PubMed 22340672https://ebm.one/en/chapter-table/scoring-system-developed-8th-international-meeting-wilson-disease-leipzig-2001
https://doi.org/10.4236/wjcd.2019.93018
Romuk E, Jachec W, Zbrojkiewicz E, Mroczek A, Niedziela J, Gasior M, Rozentryt P, Wojciechowska C. Ceruloplasmin, NT-proBNP, and Clinical Data as Risk Factors of Death or Heart Transplantation in a 1-Year Follow-Up of Heart Failure Patients. J Clin Med. 2020 Jan 3;9(1):137. doi: 10.3390/jcm9010137.
PubMed 31947878Salatzki J, Mohr I, Heins J, Cerci MH, Ochs A, Paul O, Riffel J, Andre F, Hirschberg K, Muller-Hennessen M, Giannitsis E, Friedrich MG, Merle U, Weiss KH, Katus HA, Ochs M. The impact of Wilson disease on myocardial tissue and function: a cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2021 Jun 24;23(1):84. doi: 10.1186/s12968-021-00760-1.
PubMed 34162411Chevalier K, Benyounes N, Obadia MA, Van Der Vynckt C, Morvan E, Tibi T, Poujois A. Cardiac involvement in Wilson disease: Review of the literature and description of three cases of sudden death. J Inherit Metab Dis. 2021 Sep;44(5):1099-1112. doi: 10.1002/jimd.12418. Epub 2021 Aug 2.
PubMed 34286869Quick S, Reuner U, Weidauer M, Hempel C, Heidrich FM, Mues C, Sveric KM, Ibrahim K, Reichmann H, Linke A, Speiser U. Cardiac and autonomic function in patients with Wilson's disease. Orphanet J Rare Dis. 2019 Jan 28;14(1):22. doi: 10.1186/s13023-019-1007-7.
PubMed 30691535https://doi.org/10.21608/cupsj.2021.71046.1018
Sanchez-Monteagudo A, Ripolles E, Berenguer M, Espinos C. Wilson's Disease: Facing the Challenge of Diagnosing a Rare Disease. Biomedicines. 2021 Aug 28;9(9):1100. doi: 10.3390/biomedicines9091100.
PubMed 34572285Ovchinnikova EV, Garbuz MM, Ovchinnikova AA, Kumeiko VV. Epidemiology of Wilson's Disease and Pathogenic Variants of the ATP7B Gene Leading to Diversified Protein Disfunctions. Int J Mol Sci. 2024 Feb 18;25(4):2402. doi: 10.3390/ijms25042402.
PubMed 38397079https://doi.org/10.1038/s41598-024-59377-w
Dang J, Chevalier K, Letavernier E, Tissandier C, Mouawad S, Debray D, Obadia M, Poujois A. Kidney involvement in Wilson's disease: a review of the literature. Clin Kidney J. 2024 Mar 9;17(4):sfae058. doi: 10.1093/ckj/sfae058. eCollection 2024 Apr.
PubMed 38660122
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Subtle Myocardial Dysfunction in Children With Wilson's Disease: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07765472
- Acronym / sponsor ID
- Wilson's disease and Heart
- Conditions
- Wilson's Disease, Myocardial Dysfunction, Children, Wilson Disease, Speckle Tracking Echocardiography, Electrocardiographic Changes
- Keywords
- WD, pedia, cardiac, childern, LV dysfunction, Wilson, BNP, ceruloplasmin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hebatullah FawzyUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Aug 2026 (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.
Wilson's disease (WD) is one of the most common metabolic liver diseases in older children. The most frequent clinical presentation is liver disease. However, Wilson's disease (WD) is a multisystem disorder. It is concluded that four modes of cardiac manifestations in Wilson's disease (WD) include arrhythmias, cardiomyopathy, cardiac death, and autonomic dysfunction. Such possible cardiac involvement should be added to the clinical picture of Wilson's disease (WD) involving the hepatic and central nervous system(CNS).
The data on cardiac manifestations in children is very limited and only few adult studies are available.
In this study, the investigators aim to unveil subclinical cardiac dysfunction in children with Wilson's disease with apparently normal cardiac functions by conventional assessment.
Detailed description
Wilson's disease (WD) is an autosomal recessive metabolic liver disorder caused by toxic copper accumulation. While hepatic and neurological manifestations are well recognized, copper can also accumulate in cardiac tissue, potentially leading to subtle myocardial changes, arrhythmias, and heart failure. Traditional two-dimensional (2D) echocardiography often appears normal in early stages. This study aims to evaluate early left ventricular (LV) systolic and diastolic dysfunction in pediatric patients with Wilson's disease using speckle tracking echocardiography (STE) and tissue Doppler imaging, and to correlate these findings with serum levels of Pro-Brain Natriuretic Peptide (Pro-BNP) and ceruloplasmin.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Cases) | – | Device: Echocardiography, Device: Electrocardiography, Diagnostic Test: N-terminal pro b- type natriuretic peptideChildren aged 4-18 years with confirmed Wilson's disease recruited from the Pediatric Hepatology Clinic at the National Hepatology and Tropical Medicine Research Institute (NHTMRI). |
| Group 2 (Controls) | – | Device: EchocardiographyAge- and sex-matched control children without chronic liver or cardiac illness recruited from the outpatient clinic. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- They will be divided in to 2 groups: - Group 1: Patients confirmed Wilson's disease. - Group 2: Controls. * Patients group: Patient diagnosed as WD patients, following up in Pediatric Hepatology Clinic in NHTMRI. According to Criteria of diagnosis based on Leipzig scoring system (11,12): Typical clinical symptoms and signs, as: Kayser-Fleischer rings, neurological symptoms, serum ceruloplasmin, Coombs-negative hemolytic anemia. Other tests: Liver biopsy, 24hr urinary Cu, gene analysis.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of Wilson's disease based on Leipzig scoring criteria (including clinical signs, Kayser-Fleischer rings, low ceruloplasmin, or genetic analysis).
- Age between 4 years and 18 years.
- Written informed consent obtained from parents or legal guardians.
Key exclusion criteria (4 listed)
- Children with clinical evidence of overt heart failure or known congenital heart disease.
- Children suffering from fulminant hepatitis.
- Known co-existing primary liver diseases other than Wilson's disease.
- Presence of syndromic disorders or major congenital anomalies.
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 |
|---|---|---|
| EchocardiographyAlso: Echoa safe, painless test that uses sound waves to create moving pictures of your heart's structure and pumping function. | Device | Group 1 (Cases), Group 2 (Controls) |
| ElectrocardiographyAlso: ECGa quick, painless test that records the electrical signals in the heart. | Device | Group 1 (Cases) |
| N-terminal pro b- type natriuretic peptideAlso: pro BNPa protein made by our heart, examined by peripheral blood sample. | Diagnostic test | Group 1 (Cases) |
Primary outcome
Left Ventricular Peak Longitudinal Strain (LV-PLS)
Time frame: Baseline (Day 1 , at single cross-sectional evaluation).
Left Ventricular Peak Longitudinal Strain (LV-PLS) assessed by Speckle Tracking Echocardiography (STE) to evaluate subclinical LV systolic dysfunction. Expressed as a negative percentage (%), where a less negative percentage indicates impaired function.
4 secondary outcomes
Serum Pro-Brain Natriuretic Peptide (Pro-BNP) Level
Time frame: Baseline (Day 1 , at single cross-sectional evaluation).
Tissue Doppler LV Filling Pressure (E/e' Ratio)
Time frame: Baseline (Day 1 , at single cross-sectional evaluation).
Serum Ceruloplasmin Level Correlation
Time frame: Baseline (Day 1,at time of cardiac evaluation or within 6 months preceding cardiac evaluation).
Frequency of Electrocardiographic (ECG) Abnormalities
Time frame: Baseline (Day 1 , at single cross-sectional evaluation).
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 14 Aug 2026.
- Results publication: PubMed 28753182Wiernicka A, Dadalski M, Janczyk W, Kaminska D, Naorniakowska M, Husing-Kabar A, Schmidt H, Socha P. Early Onset of Wilson Disease: Diagnostic Challenges. J Pediatr Gastroenterol Nutr. 2017 Nov;65(5):555-560. doi: 10.1097/MPG.0000000000001700.
- Results publication: PubMed 40089450European Association for the Study of the Liver. EASL-ERN Clinical Practice Guidelines on Wilson's disease. J Hepatol. 2025 Feb 22:S0168-8278(24)02706-5. doi: 10.1016/j.jhep.2024.11.007. Online ahead of print.
- Results publication: PubMed 22340672European Association for Study of Liver. EASL Clinical Practice Guidelines: Wilson's disease. J Hepatol. 2012 Mar;56(3):671-85. doi: 10.1016/j.jhep.2011.11.007.
- Results publicationhttps://ebm.one/en/chapter-table/scoring-system-developed-8th-international-meeting-wilson-disease-leipzig-2001
- Results publicationhttps://doi.org/10.4236/wjcd.2019.93018
- Results publication: PubMed 31947878Romuk E, Jachec W, Zbrojkiewicz E, Mroczek A, Niedziela J, Gasior M, Rozentryt P, Wojciechowska C. Ceruloplasmin, NT-proBNP, and Clinical Data as Risk Factors of Death or Heart Transplantation in a 1-Year Follow-Up of Heart Failure Patients. J Clin Med. 2020 Jan 3;9(1):137. doi: 10.3390/jcm9010137.
- Results publication: PubMed 34162411Salatzki J, Mohr I, Heins J, Cerci MH, Ochs A, Paul O, Riffel J, Andre F, Hirschberg K, Muller-Hennessen M, Giannitsis E, Friedrich MG, Merle U, Weiss KH, Katus HA, Ochs M. The impact of Wilson disease on myocardial tissue and function: a cardiovascular magnetic resonance study. J Cardiovasc Magn Reson. 2021 Jun 24;23(1):84. doi: 10.1186/s12968-021-00760-1.
- Results publication: PubMed 34286869Chevalier K, Benyounes N, Obadia MA, Van Der Vynckt C, Morvan E, Tibi T, Poujois A. Cardiac involvement in Wilson disease: Review of the literature and description of three cases of sudden death. J Inherit Metab Dis. 2021 Sep;44(5):1099-1112. doi: 10.1002/jimd.12418. Epub 2021 Aug 2.
- Results publication: PubMed 30691535Quick S, Reuner U, Weidauer M, Hempel C, Heidrich FM, Mues C, Sveric KM, Ibrahim K, Reichmann H, Linke A, Speiser U. Cardiac and autonomic function in patients with Wilson's disease. Orphanet J Rare Dis. 2019 Jan 28;14(1):22. doi: 10.1186/s13023-019-1007-7.
- Results publicationhttps://doi.org/10.21608/cupsj.2021.71046.1018
- Results publication: PubMed 34572285Sanchez-Monteagudo A, Ripolles E, Berenguer M, Espinos C. Wilson's Disease: Facing the Challenge of Diagnosing a Rare Disease. Biomedicines. 2021 Aug 28;9(9):1100. doi: 10.3390/biomedicines9091100.
- Results publication: PubMed 38397079Ovchinnikova EV, Garbuz MM, Ovchinnikova AA, Kumeiko VV. Epidemiology of Wilson's Disease and Pathogenic Variants of the ATP7B Gene Leading to Diversified Protein Disfunctions. Int J Mol Sci. 2024 Feb 18;25(4):2402. doi: 10.3390/ijms25042402.
- Individual participant dataSharing planned: Undecided
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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.
Hebatullah I Fawzy, Msc Student principal investigator
Faculty of medicine AinShams U,National Hepatology and Tropical Research Institute (NHTMRI)
Eman M ElSayed (Assistant Professor of Pediatrics), AssProfessor study chair
Faculty of Medicine AinShams U
Mona AH Khafagy (Lecturer of Pediatrics), Lecturer study director
Faculty of Medicine AinShams U
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson's Disease and Myocardial Dysfunction, run by Hebatullah Fawzy at 2 sites in Egypt.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Peak Longitudinal Strain (LV-PLS) (time frame: Baseline (Day 1 , at single cross-sectional evaluation).). 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 NCT07765472, which also lists 14 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 14 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.