Haemodialysis ComplicationCBKDNCT06037759
Novel Cardiovascular Biomarkers in Patients With Kidney Disease
An observational study of Haemodialysis Complication and Major Adverse Cardiac Events, run by Liverpool University Hospitals NHS Foundation Trust.
Trial summary
Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work as well as they should. End-stage kidney failure (ESKD) is the final, irreparable stage of chronic kidney disease (CKD), where kidney function has worsened, so the kidneys can no longer function independently. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haemodialysis Complication, Major Adverse Cardiac Events
- What is being tested?
- Cardiac Biomarkers, Lipidomics and Proteomics
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Nov 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged ≥45 years (or ≥18 with a history of diabetes) for both cases and controls. Cardiovascular risk steeply increases after the age of 45 years. For this exploratory analysis, we intend to target patients at high risk of cardiovascular disease.
Who may be able to join
- Patients aged≥45 years (or ≥18 with a history of diabetes). b. Cases: Incident haemodialysis patients c. A comparative arm of peritoneal dialysis patients and CKD 3-4 (not on dialysis) with hypertension as a key risk factor for CVD.
- Capable of understanding the purpose and risks of the study, fully informed, and given informed consent.
Who cannot join
- Patients with pre-existing heart disease will be excluded.
- Patients with active cancer.
Trial locations and contacts
No sites are listed yet.
About this study
Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work as well as they should. End-stage kidney failure (ESKD) is the final, irreparable stage of chronic kidney disease (CKD), where kidney function has worsened, so the kidneys can no longer function independently.
At this stage, dialysis is required to remove waste products and excess fluid from the blood. There are two types of dialysis. In haemodialysis (HD), blood is pumped out of the body to an artificial kidney machine and returned to the body by tubes that connect a person to the machine. In peritoneal dialysis (PD), the inside lining of the belly acts as a natural filter. PD has the advantage of being gentler on the heart. HD causes significant stress to the heart by reducing the blood flow to the heart muscle, resulting in heart failure, irregular rhythms, and eventually sudden heart death. A large observational study showed that HD patients had 48% worse survival in the first two years than PD patients.
Several molecules ('biomarkers') can be detected in blood and inform doctors of heart damage. Studying the form and function of proteins (Proteomics), including how they work and interact with each other inside cells in patients, could help identify the onset of heart problems. HD patients are also prone to body fat changes (cholesterol/lipids). Due to high cholesterol, there is build-up on the walls of arteries, causing their hardening. In HD patients, this process is faster due to abnormalities in lipid structure. Therefore, studying the heart biomarkers, protein, and lipid makeup of HD patients may help to find people at substantial risk of heart and vascular problems and if they are likely to become unwell due to these heart problems.
Read the detailed description
Currently, there is no specific approach to stratify CV risk in HD patients; therefore, patients are not offered targeted preventative interventions. This novel project will characterise circulating biomarkers and proteomics of myocyte damage, cardiac stress, fibrosis, and inflammation, including lipid composition. Understanding the cardiac biomarkers, targeted proteomics and lipidomics in HD patients as early predictors of CV outcomes will help better decisions on treatment choices and earlier interventions to improve outcomes in these patients. Proteomics and lipidomics, analysed with machine learning techniques, may offer new opportunities to improve risk stratification in these patients. The successful introduction of novel agents, comprising proprotein convertase subtilisin-like/kexin type 9 inhibitors, low-dose oral anticoagulants, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 agonists, anti-inflammatory agents, and icosapent ethyl, offers an opportunity to reduce the burden of recurrent CV risk further based on their risk stratification. This study aims to obtain pilot data for promising cardiac biomarkers, proteomics and lipidomics, validating them against control groups and establishing prospective changes of the new markers and their relation to the major adverse cardiac events (MACE).
Study Objectives
- To determine circulating plasma levels of new cardiac biomarkers (cMyC, galectin 3) in incident HD patients by comparing them to control groups (PD and CKD 3-4 (not on dialysis)) and to correlate with traditional biomarkers (hsTnT).
- To evaluate the lipidome as a marker of CVD risk in incident HD patients by studying the indices of HDL quality and quantity, including HDL-particle number, HDL cholesterol, apolipoprotein (apo) A-I levels, serum amyloid A (SAA) content and HDL-cholesterol efflux capacity, and paraoxonase activity of apoB-depleted serum.
- To evaluate proteomic signature as a marker of cardiac disease risk in incident HD patients by studying the proteomic platform of untargeted high-value proteins for CVD risk (as an exploratory analysis).
- To explore the association between proposed cardiac biomarkers, proteomics, lipidome and MACE (as an exploratory analysis).
- Being tested
- Cardiac Biomarkers, Lipidomics, Proteomics
- Keywords
- Chronic Kidney Disease, End Stage Kidney Disease, Haemodialysis, Biomarkers, Major Adverse Cardiac Events
- Medical subject headings
- Cardiovascular Diseases, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac BiomarkersDiagnostic test
Blood samples will be collected at baseline (within 6 weeks of dialysis start), at 6 months post-commencement and 12 months post-commencement of haemodialysis. The blood sampling will be mid-week samples taken at the dialysis start for haemodialysis patients, with a similar approach for the PD controls. For the CKD controls, the blood samples will be scheduled around routine clinic attendance, adhering where possible to the time intervals for HD cases and PD controls.
LipidomicsDiagnostic test
Blood samples will be collected at baseline (within 6 weeks of dialysis start), at 6 months post-commencement and 12 months post-commencement of haemodialysis. The blood sampling will be mid-week samples taken at the dialysis start for haemodialysis patients, with a similar approach for the PD controls. For the CKD controls, the blood samples will be scheduled around routine clinic attendance, adhering where possible to the time intervals for HD cases and PD controls.
ProteomicsDiagnostic test
Blood samples will be collected at baseline (within 6 weeks of dialysis start), at 6 months post-commencement and 12 months post-commencement of haemodialysis. The blood sampling will be mid-week samples taken at the dialysis start for haemodialysis patients, with a similar approach for the PD controls. For the CKD controls, the blood samples will be scheduled around routine clinic attendance, adhering where possible to the time intervals for HD cases and PD controls.
| Study group | Role | What they receive |
|---|---|---|
| Cases (N=50): | Patients with incident ESKD managed by HD (n=50) Receives: Diagnostic Test: Cardiac Biomarkers; Diagnostic Test: Lipidomics; Diagnostic Test: Proteomics | |
| Controls (N=50) | Patients with Incident ESKD managed by PD (n=20) Patients with CKD stage 3-4 (not on dialysis) with hypertension as a key risk factor for CKD and CVD (n=30) Receives: Diagnostic Test: Cardiac Biomarkers; Diagnostic Test: Lipidomics; Diagnostic Test: Proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events
An exploratory analysis of all-cause mortality and Major Adverse Cardiac Events (MACE). MACE is defined as a composite of CV death, Ischemic Heart Disease (IHD), myocardial infarction (MI), stroke/TIA, Heart Failure, Cardiac revascularisation (percutaneous coronary intervention and coronary artery bypass graft), carotid endarterectomy. The follow-up will be 12 months for all patients. This will be correlated with biomarker, proteomic and lipidomic data.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodialysis ComplicationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anirudh Rao, PhD, Principal investigator, Liverpool University Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037759
- Sponsor's protocol ID
- LHS0082
- Acronym
- CBKD
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: However, the samples will be bio-banked at Liverpool University Biobank which can be shared with researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Cardiovascular Biomarkers in Patients With Kidney Disease
- ClinicalTrials.gov ID
- NCT06037759
- Acronym / sponsor ID
- CBKD / LHS0082
- Keywords
- Chronic Kidney Disease, End Stage Kidney Disease, Haemodialysis, Biomarkers, Major Adverse Cardiac Events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 14 Sep 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.
Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work as well as they should. End-stage kidney failure (ESKD) is the final, irreparable stage of chronic kidney disease (CKD), where kidney function has worsened, so the kidneys can no longer function independently.
At this stage, dialysis is required to remove waste products and excess fluid from the blood. There are two types of dialysis. In haemodialysis (HD), blood is pumped out of the body to an artificial kidney machine and returned to the body by tubes that connect a person to the machine. In peritoneal dialysis (PD), the inside lining of the belly acts as a natural filter. PD has the advantage of being gentler on the heart. HD causes significant stress to the heart by reducing the blood flow to the heart muscle, resulting in heart failure, irregular rhythms, and eventually sudden heart death. A large observational study showed that HD patients had 48% worse survival in the first two years than PD patients.
Several molecules ('biomarkers') can be detected in blood and inform doctors of heart damage. Studying the form and function of proteins (Proteomics), including how they work and interact with each other inside cells in patients, could help identify the onset of heart problems. HD patients are also prone to body fat changes (cholesterol/lipids). Due to high cholesterol, there is build-up on the walls of arteries, causing their hardening. In HD patients, this process is faster due to abnormalities in lipid structure. Therefore, studying the heart biomarkers, protein, and lipid makeup of HD patients may help to find people at substantial risk of heart and vascular problems and if they are likely to become unwell due to these heart problems.
Detailed description
Currently, there is no specific approach to stratify CV risk in HD patients; therefore, patients are not offered targeted preventative interventions. This novel project will characterise circulating biomarkers and proteomics of myocyte damage, cardiac stress, fibrosis, and inflammation, including lipid composition. Understanding the cardiac biomarkers, targeted proteomics and lipidomics in HD patients as early predictors of CV outcomes will help better decisions on treatment choices and earlier interventions to improve outcomes in these patients. Proteomics and lipidomics, analysed with machine learning techniques, may offer new opportunities to improve risk stratification in these patients. The successful introduction of novel agents, comprising proprotein convertase subtilisin-like/kexin type 9 inhibitors, low-dose oral anticoagulants, sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 agonists, anti-inflammatory agents, and icosapent ethyl, offers an opportunity to reduce the burden of recurrent CV risk further based on their risk stratification. This study aims to obtain pilot data for promising cardiac biomarkers, proteomics and lipidomics, validating them against control groups and establishing prospective changes of the new markers and their relation to the major adverse cardiac events (MACE).
Study Objectives
- To determine circulating plasma levels of new cardiac biomarkers (cMyC, galectin 3) in incident HD patients by comparing them to control groups (PD and CKD 3-4 (not on dialysis)) and to correlate with traditional biomarkers (hsTnT).
- To evaluate the lipidome as a marker of CVD risk in incident HD patients by studying the indices of HDL quality and quantity, including HDL-particle number, HDL cholesterol, apolipoprotein (apo) A-I levels, serum amyloid A (SAA) content and HDL-cholesterol efflux capacity, and paraoxonase activity of apoB-depleted serum.
- To evaluate proteomic signature as a marker of cardiac disease risk in incident HD patients by studying the proteomic platform of untargeted high-value proteins for CVD risk (as an exploratory analysis).
- To explore the association between proposed cardiac biomarkers, proteomics, lipidome and MACE (as an exploratory analysis).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases (N=50): | – | Diagnostic Test: Cardiac Biomarkers, Diagnostic Test: Lipidomics, Diagnostic Test: ProteomicsPatients with incident ESKD managed by HD (n=50) |
| Controls (N=50) | – | Diagnostic Test: Cardiac Biomarkers, Diagnostic Test: Lipidomics, Diagnostic Test: ProteomicsPatients with Incident ESKD managed by PD (n=20) Patients with CKD stage 3-4 (not on dialysis) with hypertension as a key risk factor for CKD and CVD (n=30) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged ≥45 years (or ≥18 with a history of diabetes) for both cases and controls. Cardiovascular risk steeply increases after the age of 45 years. For this exploratory analysis, we intend to target patients at high risk of cardiovascular disease.
Key inclusion criteria (2 listed)
- Patients aged≥45 years (or ≥18 with a history of diabetes). b. Cases: Incident haemodialysis patients c. A comparative arm of peritoneal dialysis patients and CKD 3-4 (not on dialysis) with hypertension as a key risk factor for CVD.
- Capable of understanding the purpose and risks of the study, fully informed, and given informed consent.
Key exclusion criteria (2 listed)
- Patients with pre-existing heart disease will be excluded.
- Patients with active cancer.
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 |
|---|---|---|
| Cardiac BiomarkersBlood samples will be collected at baseline (within 6 weeks of dialysis start), at 6 months post-commencement and 12 months post-commencement of haemodialysis. The blood sampling will be mid-week samples taken at the dialysis start for haemodialysis patients, with a similar approach for the PD controls. For the CKD controls, the blood samples will be scheduled around routine clinic attendance, adhering where possible to the time intervals for HD cases and PD controls. | Diagnostic test | Cases (N=50):, Controls (N=50) |
| LipidomicsBlood samples will be collected at baseline (within 6 weeks of dialysis start), at 6 months post-commencement and 12 months post-commencement of haemodialysis. The blood sampling will be mid-week samples taken at the dialysis start for haemodialysis patients, with a similar approach for the PD controls. For the CKD controls, the blood samples will be scheduled around routine clinic attendance, adhering where possible to the time intervals for HD cases and PD controls. | Diagnostic test | Cases (N=50):, Controls (N=50) |
| ProteomicsBlood samples will be collected at baseline (within 6 weeks of dialysis start), at 6 months post-commencement and 12 months post-commencement of haemodialysis. The blood sampling will be mid-week samples taken at the dialysis start for haemodialysis patients, with a similar approach for the PD controls. For the CKD controls, the blood samples will be scheduled around routine clinic attendance, adhering where possible to the time intervals for HD cases and PD controls. | Diagnostic test | Cases (N=50):, Controls (N=50) |
Primary outcome
Major Adverse Cardiac Events
Time frame: 12 months
An exploratory analysis of all-cause mortality and Major Adverse Cardiac Events (MACE). MACE is defined as a composite of CV death, Ischemic Heart Disease (IHD), myocardial infarction (MI), stroke/TIA, Heart Failure, Cardiac revascularisation (percutaneous coronary intervention and coronary artery bypass graft), carotid endarterectomy. The follow-up will be 12 months for all patients. This will be correlated with biomarker, proteomic and lipidomic data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No. However, the samples will be bio-banked at Liverpool University Biobank which can be shared with researchers.
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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.
Anirudh Rao, PhD principal investigator
Liverpool University Hospital NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Haemodialysis Complication and Major Adverse Cardiac Events, run by Liverpool University Hospitals NHS Foundation Trust.
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 2 inclusion and 2 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Anirudh Rao, PhD (01517063487, anirudh.rao@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (time frame: 12 months). 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 18 Sep 2023.