Biomarkers and Event Patterns of Vascular Disease in Hemodialysis

Cross-sectional Biomarker Study for Vascular Calcification in Hemodialysis Patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07170761

Acronym

HEMOcalc

Enrollment

475

Registered

2025-09-12

Start date

2022-10-15

Completion date

2027-12-31

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, Vascular Disease

Brief summary

Parathyroid hormone (PTH) remains the central biomarker to classify CKD-metabolic bone disease (CKD-MBD) in hemodialysis patients. While PTH-values are known to be associated with adverse outcomes, interventional studies have failed to show a benefit of pharmacological modulation of PTH levels on hard clinical outcomes. To address this gap, the investigators explored alternative markers of bone metabolism, vascular calcification and inflammation in association to prospective event patterns.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Stable hemodialysis \> 3 months duration

Exclusion criteria

* Pregnancy * Acute infections or antibiotic treatment (within 4 weeks)

Design outcomes

Primary

Measure	Time frame	Description
Mortality	1, 2 and 3 years	All-causes, the date of death will be recorded.

Secondary

Measure	Time frame	Description
Cause-specific mortality	1, 2 and 3 years	The cause of death will be recorded.
MACE	1, 2 and 3 years	The number of participants with, the date and cause of MACE (The 4-point MACE is a composite outcome measure of non-fatal stroke and myocardial infarction, urgent angina and fatal cardiovascular events) will be recorded from medical record review.
The number of participants with hospitalisation for Infection	1, 2 and 3 years	The number and dates of hospitalisations for any infectious diseases (such as pneumonia, sepsis or urinary tract infection) will be recorded from medical record review.
The number of participants with hospitalisation for Heart failure	1, 2 and 3 years	The number and dates of hospitalisations for heart failure (such as acute heart failure or decompensated chronic heart failure) will be recorded from medical record review.
The number of participants with Fractures	1, 2 and 3 years	The number and dates of fractures (classified by anatomical site, such as hip, vertebral, or upper limb) will be recorded from medical record review.
The number of participants with Bleeding events	1, 2 and 3 years	The number and dates of bleeding events (classified as major or minor according to ISTH definition) will be recorded from medical record review.
The number of participants with Interventions for vascular diseases	1, 2 and 3 years	The number and dates of surgical and endovascular interventions (such as revascularization, bypass or amputation) for atherosclerotic cardiovascular diseases (such as coronary and peripheral artery disease) will be recorded from medical record review.

Countries

Austria

Contacts

PRINCIPAL_INVESTIGATORKathrin Eller, Univ.-Prof.

Division of Nephrology, Department of Internal Medicine, Medical University of Graz, Graz, Austria

Outcome results