Novel Cardiovascular Biomarkers in Patients With Kidney Disease

NCT06037759 | Not Yet Recruiting

• 1 other identifier: LHS0082
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Haemodialysis Complication; Major Adverse Cardiac Events

Keywords

Chronic Kidney Disease; End Stage Kidney Disease; Haemodialysis; Biomarkers; Major Adverse Cardiac Events

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (2)

Cases (N=50):

Patients with incident ESKD managed by HD (n=50)

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)

Diagnostic Test: Cardiac Biomarkers; Diagnostic Test: Lipidomics; Diagnostic Test: Proteomics

Interventions

Cardiac Biomarkers DIAGNOSTIC_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.

Cases (N=50):; Controls (N=50)

Lipidomics DIAGNOSTIC_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.

Cases (N=50):; Controls (N=50)

Proteomics DIAGNOSTIC_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.

Cases (N=50):; Controls (N=50)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• d. Capable of understanding the purpose and risks of the study, fully informed, and given informed consent.

You may not qualify if:

• Patients with pre-existing heart disease will be excluded.
• Patients with active cancer.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Up to 30ml of blood will be collected for processing to serum or plasma/red cell pellet for downstream analysis. Novel Biomarkers: Galactin-3, cMyC, Troponin. Lipidomics Proteomics

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anirudh Rao, PhD

  Liverpool University Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anirudh Rao, PhD

CONTACT

01517063487; anirudh.rao@liverpoolft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share