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NCT Number: NCT07130721

Assessment of D-dimer and CRP for Cardiovascular Risk Prediction in Hemodialysis Patients

This study aims to assess whether two blood markers - C-reactive protein (CRP) and D-dimer - can help predict cardiovascular complications in patients undergoing regular hemodialysis. Cardiovascular disease is a common and serious problem in dialysis patients, and early detection is important.

the study will include 100 adult patients from the Hemodialysis Unit at Assiut University Hospital. Participants will be divided into two groups: those with and those without known heart disease. Each participant will have a one-time blood test to measure CRP and D-dimer levels. In addition, an electrocardiogram (ECG) will be done once to check for signs of heart problems.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location contact

Mennat Allah M Ahmed, M.B.B.Ch

PRINCIPAL_INVESTIGATOR

About this study

This cross-sectional study is designed to explore the potential role of hematologic biomarkers in predicting cardiovascular complications among patients undergoing maintenance hemodialysis. Cardiovascular disease is a leading cause of morbidity and mortality in this population, and systemic inflammation and hypercoagulability are thought to contribute significantly to adverse outcomes.

C-reactive protein (CRP) is a well-established marker of systemic inflammation, while D-dimer reflects activation of the coagulation and fibrinolytic pathways. Both biomarkers have been associated with increased cardiovascular risk in the general population, but their predictive value in hemodialysis patients remains insufficiently characterized.

A total of 100 adult patients on maintenance hemodialysis will be evaluated. The population will be stratified into two groups based on the presence or absence of clinically confirmed cardiovascular disease. Laboratory analysis will include measurement of CRP and D-dimer, and cardiovascular assessment will include a standard 12-lead ECG. Clinical and demographic data will also be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years

On regular hemodialysis for at least 3 months

Able and willing to provide informed consent

Group I: Hemodialysis patients with no clinically documented cardiovascular disease

Group II: Hemodialysis patients with confirmed cardiovascular disease (by medical records, ECGs, echocardiography, or documented hospital admissions)

Exclusion criteria

  • Acute or recent infection (within the past 4 weeks)

Use of anticoagulant or antiplatelet therapy

Active malignancy

Autoimmune or chronic inflammatory disease

Known bleeding or thrombotic disorders

Pregnancy

Treatment and study plan

C-Reactive Protein (CRP) Test

Diagnostic Test

Blood samples will be collected once from all participants to measure CRP levels

D-dimer test

Diagnostic Test

D-dimer levels will be assessed once to evaluate thrombotic risk.

Electrocardiogram (ECG)

Diagnostic Test

A standard 12-lead ECG will be performed once per participant to assess cardiovascular status

Primary outcomes

  1. Serum CRP level among hemodialysis patients

    Time frame: At baseline (one-time measurement)

    To assess the level of serum CRP in hemodialysis patients with and without cardiovascular disease and compare values between the two groups to explore possible associations

  2. Plasma D-dimer level among hemodialysis patients

    Time frame: At baseline (one-time measurement)

    To assess the level of plasma D-dimer in hemodialysis patients with and without cardiovascular disease and compare values between the two groups to explore possible associations.

Secondary outcomes

  1. Presence of cardiovascular abnormalities on ECG

    Time frame: At baseline (one-time measurement)

    To assess cardiovascular status of hemodialysis patients using a standard 12-lead ECG and record the presence of abnormal findings

Study contacts

Contact information is provided by the study sponsor or research team.

Mennat Allah M Ahmed, M.B.B.Ch.

CONTACT

[email protected]

+201030830488

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of Blood Biomarkers (D-dimer and C-Reactive Protein) in Predicting Cardiovascular Complications Among Hemodialysis Patients: A Cross-Sectional Study

Acronym: BIOCARD-HD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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