End Stage Renal Disease on DialysisBIOCARD-HDNCT07130721
Assessment of D-dimer and CRP for Cardiovascular Risk Prediction in Hemodialysis Patients
An observational study of End Stage Renal Disease on Dialysis, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- C-Reactive Protein (CRP) Test, D-dimer Test and Electrocardiogram (ECG)
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodialysis patients treated at the Hemodialysis Unit of Assiut University Hospital, including those with and without documented cardiovascular disease.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Hospital
Asyut, Asyut Governorate, 71515
Mennat Allah M Ahmed, M.B.B.Ch
About this study
Official title: Assessment of Blood Biomarkers (D-dimer and C-Reactive Protein) in Predicting Cardiovascular Complications Among Hemodialysis Patients: A Cross-Sectional Study
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.
Read the detailed description
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.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- C-Reactive Protein (CRP) Test, D-dimer Test, Electrocardiogram (ECG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Reactive Protein (CRP) TestDiagnostic test
Blood samples will be collected once from all participants to measure CRP levels
D-dimer TestDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients without Cardiovascular Disease | Patients undergoing regular hemodialysis for at least 3 months with no clinically documented cardiovascular disease. Cardiovascular status is confirmed by reviewing medical records, ECGs, and other relevant reports. Receives: Diagnostic Test: C-Reactive Protein (CRP) Test; Diagnostic Test: D-dimer Test; Diagnostic Test: Electrocardiogram (ECG) | |
| Hemodialysis Patients with Cardiovascular Disease | Patients undergoing regular hemodialysis for at least 3 months with confirmed cardiovascular disease based on medical records, ECGs, echocardiography, or documented hospital admissions Receives: Diagnostic Test: C-Reactive Protein (CRP) Test; Diagnostic Test: D-dimer Test; Diagnostic Test: Electrocardiogram (ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CRP level among hemodialysis patients
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
Measured: At baseline (one-time measurement)
Plasma D-dimer level among hemodialysis patients
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.
Measured: At baseline (one-time measurement)
Secondary outcomes (1)
Presence of cardiovascular abnormalities on ECG
To assess cardiovascular status of hemodialysis patients using a standard 12-lead ECG and record the presence of abnormal findings
Measured: At baseline (one-time measurement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Allah Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130721
- Sponsor's protocol ID
- 04-2025-201318
- Acronym
- BIOCARD-HD
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because the study involves sensitive health data and patient confidentiality must be maintained.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Blood Biomarkers (D-dimer and C-Reactive Protein) in Predicting Cardiovascular Complications Among Hemodialysis Patients: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07130721
- Acronym / sponsor ID
- BIOCARD-HD / 04-2025-201318
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 19 Aug 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Patients without Cardiovascular Disease | – | Diagnostic Test: C-Reactive Protein (CRP) Test, Diagnostic Test: D-dimer Test, Diagnostic Test: Electrocardiogram (ECG)Patients undergoing regular hemodialysis for at least 3 months with no clinically documented cardiovascular disease. Cardiovascular status is confirmed by reviewing medical records, ECGs, and other relevant reports. |
| Hemodialysis Patients with Cardiovascular Disease | – | Diagnostic Test: C-Reactive Protein (CRP) Test, Diagnostic Test: D-dimer Test, Diagnostic Test: Electrocardiogram (ECG)Patients undergoing regular hemodialysis for at least 3 months with confirmed cardiovascular disease based on medical records, ECGs, echocardiography, or documented hospital admissions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients treated at the Hemodialysis Unit of Assiut University Hospital, including those with and without documented cardiovascular disease.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| C-Reactive Protein (CRP) TestBlood samples will be collected once from all participants to measure CRP levels | Diagnostic test | Hemodialysis Patients with Cardiovascular Disease, Hemodialysis Patients without Cardiovascular Disease |
| D-dimer TestD-dimer levels will be assessed once to evaluate thrombotic risk. | Diagnostic test | Hemodialysis Patients with Cardiovascular Disease, Hemodialysis Patients without Cardiovascular Disease |
| Electrocardiogram (ECG)A standard 12-lead ECG will be performed once per participant to assess cardiovascular status | Diagnostic test | Hemodialysis Patients with Cardiovascular Disease, Hemodialysis Patients without Cardiovascular Disease |
Primary outcome
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
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.
1 secondary outcome
Presence of cardiovascular abnormalities on ECG
Time frame: At baseline (one-time measurement)
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 Aug 2025.
- Individual participant dataSharing planned: No. IPD will not be shared because the study involves sensitive health data and patient confidentiality must be maintained.
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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.
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 End Stage Renal Disease on Dialysis, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Aug 2025. 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 Egypt. 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 Mennat Allah M Ahmed, M.B.B.Ch. (+201030830488, Menna.15259031@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CRP level among hemodialysis patients (time frame: At baseline (one-time measurement)). The study lists 2 primary outcomes in all. 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 Aug 2025.