Heart FailureNCT05958706
Mitochondrial Substrate Utilization in the Diabetic Human Heart
An observational study of Heart Failure and Type2diabetes, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Heart Failure, Type2diabetes, Insulin Resistance
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to Jun 2035
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with heart failure with or without T2DM undergoing endomyocardial biopsy for clinical reasons (WP1), patients with terminal heart failure with or without T2DM undergoing left ventricular assist device surgery or heart transplantation (WP2), and patients after heart transplantation with and without T2DM undergoing endomyocardial biopsy for clinical reasons (post-transplant surveillance).
Who may be able to join
- Age ≥ 20 and ≤ 85 years
- Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus.
- Written informed consent
Who cannot join
- Acute infectious diseases within the last 2 weeks before the examination
- Autoimmune diseases or acute immunocompromising diseases (leukocytes < 5000/μl)
- Pregnancy
- Use of alcohol or drugs (addiction), psychiatric diseases
- Suspected or manifest AIDS (HIV); hepatitis B or C.
- Liver disease not attributed to the presence of nonalcoholic fatty liver hepatitis or congestive hepatopathy in heart failure
Show all 9Show fewer
- Malignant cancer
- Lack of capacity to give informed consent or lack of consent to participate in the study
- For MRI study with drug stress: contraindications to the use of regadenoson, specifically: a) Hypersensitivity to the active ingredient or any of the other ingredients mentioned. b) Second- or third-degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning pacemaker. c) Unstable angina that has not been stabilized with medication. d) Severe hypotension. e) Decompensated stages of heart failure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Lisa Dannenberg, MD, lisa.dannenberg@med.uni-duesseldorf.de
Clinical Trial Unit, +49211811800, ctu@med.uni-duesseldorf.de
About this study
Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control/T2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.
Read the detailed description
Insulin resistance, ectopic lipid accumulation in the liver, and plasma concentrations of free fatty acids are independent predictors of cardiac mortality, the primary cause of death in patients with type 2 diabetes mellitus (T2DM). T2DM predisposes to the development of heart failure independently of other risk factors. Ventricular dysfunction in diabetic patients independent of coronary artery disease or arterial hypertension is termed diabetic cardiomyopathy. Studies suggest that myocardial mitochondrial dysfunction, as well as accumulation of lipids and other metabolites, oxidative stress, and altered insulin signaling, play a significant role in the pathogenesis of diabetic cardiomyopathy. Thus, we also found evidence of impaired mitochondrial function in hyperglycemia and insulin resistance in previous analyses. Nevertheless, it remains unclear, among other things, at which point of mitochondrial metabolism the shown impairments originate, whether the availability of different substrates may influence these effects, what is the temporal sequence of pathomechanistic events, and what are the effect modifiers for the influence of T2DM on the myocardium.
The goal of the present work is to more precisely characterize the underlying pathomechanisms to answer these questions. The focus will be on respirometric analysis of human myocardial tissue samples established by our preliminary work. In previously published studies, we were able to establish its use for the first time in catheter-guided endomyocardial biopsies. By studying further heart failure and heart transplant patients, we will analyze the importance of myocardial mitochondrial function as a prognostic marker of further disease progression and, using larger power, investigate the influence of different effect modifiers.
The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.
Hypotheses:
- the reduced mitochondrial oxidative capacity of myocardial mitochondria in T2DM is complex- and substrate-specific.
- within patients with heart failure of unclear etiology and indication for myocardial biopsy, there are mitochondrial profiles with different clinical courses and outcomes.
- in T2DM, myocardial oxidative capacity is also longitudinally impaired in heart transplant patients and this impairment is associated with worse clinical outcome.
Objectives:
- identify specific targets for therapeutic strategies against diabetic cardiomyopathy: work program (WP) 1.
- characterization of myocardial mitochondrial function and its relevance to clinical phenotypes in heart failure: WP 2.
- investigation of T2DM as a longitudinal predictor of worse mitochondrial and clinical cardiac function in heart transplant patients: WP 3.
WP1:
The aim is to identify altered respiratory chain subcomponents and metabolic pathways associated with the development of manifest diabetic cardiomyopathy in T2DM. For this purpose, patients with and without T2DM (according to the criteria of the "American Diabetes Association" (ADA)) who have an indication for endomyocardial biopsy on clinical grounds will be included. A matched comparison between patients with and without T2DM will provide evidence of diagnostic and therapeutic targets for diabetic cardiomyopathy in newly diagnosed heart failure (with and without left ventricular ejection fraction limitation).
Patients:
- Group 1: Patients with manifest heart failure (NYHA II-IV) with clinical indication to perform myocardial biopsy and T2DM according to the "American Diabetes Association" (ADA) criteria, HbA1c < 9.0%, with/without therapy (insulin, oral/parenteral antidiabetic drugs).
- Group 2: Patients with manifest heart failure (NYHA II-IV) with clinical indication to perform myocardial biopsy without T2DM.
WP2:
The aim is to characterize myocardial mitochondrial function and its relevance for clinical phenotypes in heart failure. For this purpose, patients with terminal heart failure from the heart failure program of the Department of Cardiology, Pneumology and Angiology of the University Hospital Düsseldorf who are scheduled for implantation of a left ventricular assist device (LVAD) or are undergoing heart transplantation will be included.
All study examinations of myocardial tissue are performed in an area of the left ventricular apex obtained during surgery (LVAD implantation or cardiac harvest), which is not further clinically analyzed or preserved and which therefore no longer has any direct benefit for the patients.
Patients:
- Group 1: Patients with terminal heart failure and diagnosed T2DM according to the "American Diabetes Association" (ADA) criteria 18, HbA1c < 9.0%, with/without therapy (insulin, oral/parenteral antidiabetic drugs).
- Group 2: Patients with terminal heart failure (NYHA IV) without T2DM.
WP3:
The aim is to investigate T2DM as a longitudinal predictor of impaired mitochondrial and clinical cardiac function in heart transplant patients. For this purpose, patients who are included in the heart transplantation follow-up program of the University Hospital Düsseldorf and have the indication for endomyocardial biopsy within this program will be included. Routine myocardial biopsy is necessary in these patients to detect subclinical graft rejection early, as it is associated with increased mortality. Biopsies occur multiple times in the first year after transplantation, and in subsequent years (if there is no evidence of rejection), the goal is to monitor annually.
Patients:
- Group 1: Patients after heart transplantation with diagnosed T2DM according to the "American Diabetes Association" (ADA) criteria 18, HbA1c < 9.0%, with/without therapy (insulin, oral/parenteral antidiabetic drugs).
- Group 2: Patients after heart transplantation without T2DM.
- Conditions
- Heart Failure, Type2diabetes, Insulin Resistance, Mitochondrial Diseases, Diabetic Cardiomyopathies
- Keywords
- mitochondrial function, respirometry, heart failure, type 2 diabetes mellitus, insulin resistance, mitochondrial disease, diabetic cardiomyopathy
- Medical subject headings
- Heart Failure, Insulin Resistance, Mitochondrial Diseases, Diabetic Cardiomyopathies, Diabetes Mellitus, Type 2
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 |
|---|---|---|
| patients with manifest heart failure | patients with manifest heart failure and T2DM or patients with manifest heart failure without T2DM | |
| patients with terminal heart failure | patients with terminal heart failure and T2DM or patients with terminal heart failure without T2DM | |
| patients after heart transplantation | patients after heart transplantation and T2DM or patients after heart transplantation without T2DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substrate-specific JVO2 of ventricular myocardial mitochondrial oxidative capacity
measured in (pmol/s*mg)
Measured: at time of the endomyocardial biopsy procedure
Secondary outcomes (10)
Markers of cardiac function and structure
measured by cardiac magnet resonance tomography
Measured: 1 day before or after endomyocardial biopsy
Markers of cardiac function
measured by echocardiography
Measured: 1 day before or after endomyocardial biopsy
Cardiac substrate utilization
measured by cardiac magnet resonance spectroscopy (MRS)
Measured: 1 day before or after endomyocardial biopsy
Patterns in the myocardial transcriptome and systemic metabolome
Measured: at time of the endomyocardial biopsy procedure
non-fatal myocardial infarction
Survival and clinical outcomes after study index visit (inclusion)
Measured: up to 5 years (follow-up in clinical routine)
all-cause mortality
Survival and clinical outcomes after study index visit (inclusion)
Measured: up to 5 years (follow-up in clinical routine)
allograft rejection
Survival and clinical outcomes after study index visit (inclusion)
Measured: up to 5 years (follow-up in clinical routine)
hospitalization for heart failure
Survival and clinical outcomes after study index visit (inclusion)
Measured: up to 5 years (follow-up in clinical routine)
non-fatal stroke
Survival and clinical outcomes after study index visit (inclusion)
Measured: up to 5 years (follow-up in clinical routine)
Longitudinal Substrate-specific JVO2
measured with sequential biopsies
Measured: variable, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Dec 2021
- Primary completionJun 2030 (estimated)
- Study completionJun 2035 (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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malte Kelm, Prof., Study chair, Clinic for Cardiology, Pneumology and Angiology at University Hospital DüsseldorfElric Zweck, MD, Principal investigator, Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958706
- Sponsor's protocol ID
- 2022-1962
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Substrate Utilization in the Diabetic Human Heart
- ClinicalTrials.gov ID
- NCT05958706
- Acronym / sponsor ID
- 2022-1962
- Conditions
- Heart Failure, Type2diabetes, Insulin Resistance, Mitochondrial Diseases, Diabetic Cardiomyopathies
- Keywords
- mitochondrial function, respirometry, heart failure, type 2 diabetes mellitus, insulin resistance, mitochondrial disease, diabetic cardiomyopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 25 Jul 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.
Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control/T2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.
Detailed description
Insulin resistance, ectopic lipid accumulation in the liver, and plasma concentrations of free fatty acids are independent predictors of cardiac mortality, the primary cause of death in patients with type 2 diabetes mellitus (T2DM). T2DM predisposes to the development of heart failure independently of other risk factors. Ventricular dysfunction in diabetic patients independent of coronary artery disease or arterial hypertension is termed diabetic cardiomyopathy. Studies suggest that myocardial mitochondrial dysfunction, as well as accumulation of lipids and other metabolites, oxidative stress, and altered insulin signaling, play a significant role in the pathogenesis of diabetic cardiomyopathy. Thus, we also found evidence of impaired mitochondrial function in hyperglycemia and insulin resistance in previous analyses. Nevertheless, it remains unclear, among other things, at which point of mitochondrial metabolism the shown impairments originate, whether the availability of different substrates may influence these effects, what is the temporal sequence of pathomechanistic events, and what are the effect modifiers for the influence of T2DM on the myocardium.
The goal of the present work is to more precisely characterize the underlying pathomechanisms to answer these questions. The focus will be on respirometric analysis of human myocardial tissue samples established by our preliminary work. In previously published studies, we were able to establish its use for the first time in catheter-guided endomyocardial biopsies. By studying further heart failure and heart transplant patients, we will analyze the importance of myocardial mitochondrial function as a prognostic marker of further disease progression and, using larger power, investigate the influence of different effect modifiers.
The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.
Hypotheses:
- the reduced mitochondrial oxidative capacity of myocardial mitochondria in T2DM is complex- and substrate-specific.
- within patients with heart failure of unclear etiology and indication for myocardial biopsy, there are mitochondrial profiles with different clinical courses and outcomes.
- in T2DM, myocardial oxidative capacity is also longitudinally impaired in heart transplant patients and this impairment is associated with worse clinical outcome.
Objectives:
- identify specific targets for therapeutic strategies against diabetic cardiomyopathy: work program (WP) 1.
- characterization of myocardial mitochondrial function and its relevance to clinical phenotypes in heart failure: WP 2.
- investigation of T2DM as a longitudinal predictor of worse mitochondrial and clinical cardiac function in heart transplant patients: WP 3.
WP1:
The aim is to identify altered respiratory chain subcomponents and metabolic pathways associated with the development of manifest diabetic cardiomyopathy in T2DM. For this purpose, patients with and without T2DM (according to the criteria of the "American Diabetes Association" (ADA)) who have an indication for endomyocardial biopsy on clinical grounds will be included. A matched comparison between patients with and without T2DM will provide evidence of diagnostic and therapeutic targets for diabetic cardiomyopathy in newly diagnosed heart failure (with and without left ventricular ejection fraction limitation).
Patients:
- Group 1: Patients with manifest heart failure (NYHA II-IV) with clinical indication to perform myocardial biopsy and T2DM according to the "American Diabetes Association" (ADA) criteria, HbA1c < 9.0%, with/without therapy (insulin, oral/parenteral antidiabetic drugs).
- Group 2: Patients with manifest heart failure (NYHA II-IV) with clinical indication to perform myocardial biopsy without T2DM.
WP2:
The aim is to characterize myocardial mitochondrial function and its relevance for clinical phenotypes in heart failure. For this purpose, patients with terminal heart failure from the heart failure program of the Department of Cardiology, Pneumology and Angiology of the University Hospital Düsseldorf who are scheduled for implantation of a left ventricular assist device (LVAD) or are undergoing heart transplantation will be included.
All study examinations of myocardial tissue are performed in an area of the left ventricular apex obtained during surgery (LVAD implantation or cardiac harvest), which is not further clinically analyzed or preserved and which therefore no longer has any direct benefit for the patients.
Patients:
- Group 1: Patients with terminal heart failure and diagnosed T2DM according to the "American Diabetes Association" (ADA) criteria 18, HbA1c < 9.0%, with/without therapy (insulin, oral/parenteral antidiabetic drugs).
- Group 2: Patients with terminal heart failure (NYHA IV) without T2DM.
WP3:
The aim is to investigate T2DM as a longitudinal predictor of impaired mitochondrial and clinical cardiac function in heart transplant patients. For this purpose, patients who are included in the heart transplantation follow-up program of the University Hospital Düsseldorf and have the indication for endomyocardial biopsy within this program will be included. Routine myocardial biopsy is necessary in these patients to detect subclinical graft rejection early, as it is associated with increased mortality. Biopsies occur multiple times in the first year after transplantation, and in subsequent years (if there is no evidence of rejection), the goal is to monitor annually.
Patients:
- Group 1: Patients after heart transplantation with diagnosed T2DM according to the "American Diabetes Association" (ADA) criteria 18, HbA1c < 9.0%, with/without therapy (insulin, oral/parenteral antidiabetic drugs).
- Group 2: Patients after heart transplantation without T2DM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with manifest heart failure | – | –patients with manifest heart failure and T2DM or patients with manifest heart failure without T2DM |
| patients with terminal heart failure | – | –patients with terminal heart failure and T2DM or patients with terminal heart failure without T2DM |
| patients after heart transplantation | – | –patients after heart transplantation and T2DM or patients after heart transplantation without T2DM |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure with or without T2DM undergoing endomyocardial biopsy for clinical reasons (WP1), patients with terminal heart failure with or without T2DM undergoing left ventricular assist device surgery or heart transplantation (WP2), and patients after heart transplantation with and without T2DM undergoing endomyocardial biopsy for clinical reasons (post-transplant surveillance).
Key inclusion criteria (3 listed)
- Age ≥ 20 and ≤ 85 years
- Male and female patients with manifest heart failure (NYHA II-IV) and clinical indication for myocardial biopsy or after transplantation and clinical indication for myocardial biopsy with or without type II diabetes mellitus or terminal (NYHA IV) heart failure with or without type II diabetes mellitus.
- Written informed consent
Key exclusion criteria (9 listed)
- Acute infectious diseases within the last 2 weeks before the examination
- Autoimmune diseases or acute immunocompromising diseases (leukocytes < 5000/μl)
- Pregnancy
- Use of alcohol or drugs (addiction), psychiatric diseases
- Suspected or manifest AIDS (HIV); hepatitis B or C.
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
Substrate-specific JVO2 of ventricular myocardial mitochondrial oxidative capacity
Time frame: at time of the endomyocardial biopsy procedure
measured in (pmol/s*mg)
10 secondary outcomes
Markers of cardiac function and structure
Time frame: 1 day before or after endomyocardial biopsy
Markers of cardiac function
Time frame: 1 day before or after endomyocardial biopsy
Cardiac substrate utilization
Time frame: 1 day before or after endomyocardial biopsy
Patterns in the myocardial transcriptome and systemic metabolome
Time frame: at time of the endomyocardial biopsy procedure
non-fatal myocardial infarction
Time frame: up to 5 years (follow-up in clinical routine)
all-cause mortality
Time frame: up to 5 years (follow-up in clinical routine)
allograft rejection
Time frame: up to 5 years (follow-up in clinical routine)
hospitalization for heart failure
Time frame: up to 5 years (follow-up in clinical routine)
non-fatal stroke
Time frame: up to 5 years (follow-up in clinical routine)
Longitudinal Substrate-specific JVO2
Time frame: variable, up to 2 years
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 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Malte Kelm, Prof. study chair
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
Elric Zweck, MD principal investigator
Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf
1 site 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 and Type2diabetes, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 9 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 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Elric Zweck, MD (+492118118800, elric.zweck@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substrate-specific JVO2 of ventricular myocardial mitochondrial oxidative capacity (time frame: at time of the endomyocardial biopsy procedure). 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 Feb 2026.