Systemic SclerosisNCT07209644
Catestatin as a Novel Biomarker for Cardiovascular and Microvascular Involvement in Systemic Sclerosis
An observational study of Systemic Sclerosis, run by Assiut University.
Trial summary
This study investigates the relationship between serum catestatin levels and systemic sclerosis (SSc), with a focus on cardiovascular involvement and microvascular alterations, to determine catestatin's potential as a biomarker of disease activity and severity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will include 35 patients diagnosed with systemic sclerosis according to the 2013 ACR-EULAR classification criteria and 35 age- and sex-matched healthy controls without autoimmune or cardiovascular diseases. Patients must be over 18 years old, and both genders will be included. Controls will be recruited from hospital staff and volunteers. Exclusion criteria eliminate any confounding factors affecting serum catestatin, including other autoimmune diseases, comorbid cardiovascular conditions unrelated to SSc, diabetes, chronic kidney disease, and obesity.
Who may be able to join
- Patients diagnosed with systemic sclerosis according to 2013 ACR-EULAR classification criteria.
- Age >18 years.
Who cannot join
- Other autoimmune disorders.
- Cardiovascular conditions not linked to systemic sclerosis.
- Comorbidities affecting catestatin metabolism (e.g., diabetes, chronic kidney disease, obesity).
About this study
Official title: Serum Catestatin in Systemic Sclerosis: Relations to Cardiovascular Involvement and Microvascular Alterations
This study investigates the relationship between serum catestatin levels and systemic sclerosis (SSc), with a focus on cardiovascular involvement and microvascular alterations, to determine catestatin's potential as a biomarker of disease activity and severity.
Read the detailed description
Systemic sclerosis is a chronic autoimmune disease characterized by fibrosis, autoimmunity, and vasculopathy, with cardiovascular complications accounting for a significant proportion of morbidity and mortality. Despite advances in diagnostic tools, early identification of high-risk patients remains challenging. Catestatin, a peptide derived from chromogranin A, has recently gained attention as a biomarker with regulatory roles in cardiovascular physiology, including hypertension, endothelial function, and vascular remodeling. This cross-sectional study will assess serum catestatin levels in patients with SSc compared with healthy controls. It aims to correlate these levels with disease activity indices, cardiovascular involvement (using echocardiography, ECG, and blood pressure monitoring), and microvascular abnormalities identified via nailfold capillaroscopy. Findings from this study may establish catestatin as a promising biomarker, paving the way for improved management and cardiovascular risk stratification in SSc patients.
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Sclerosis Arm | Patients with systemic sclerosis (n=35), assessed for disease activity, catestatin levels, cardiovascular involvement, and microvascular changes. | |
| Control Arm | Healthy controls (n=35), evaluated for serum catestatin levels to provide a baseline reference. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in level of serum catestatin concentration in systemic sclerosis patients compared with healthy controls.
Quantification of serum catestatin levels using ELISA, directly compared between the two study groups.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa awwad abdoh radwan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209644
- Sponsor's protocol ID
- Serum Catestatin
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Catestatin in Systemic Sclerosis: Relations to Cardiovascular Involvement and Microvascular Alterations
- ClinicalTrials.gov ID
- NCT07209644
- Acronym / sponsor ID
- Serum Catestatin
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 Oct 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 investigates the relationship between serum catestatin levels and systemic sclerosis (SSc), with a focus on cardiovascular involvement and microvascular alterations, to determine catestatin's potential as a biomarker of disease activity and severity.
Detailed description
Systemic sclerosis is a chronic autoimmune disease characterized by fibrosis, autoimmunity, and vasculopathy, with cardiovascular complications accounting for a significant proportion of morbidity and mortality. Despite advances in diagnostic tools, early identification of high-risk patients remains challenging. Catestatin, a peptide derived from chromogranin A, has recently gained attention as a biomarker with regulatory roles in cardiovascular physiology, including hypertension, endothelial function, and vascular remodeling. This cross-sectional study will assess serum catestatin levels in patients with SSc compared with healthy controls. It aims to correlate these levels with disease activity indices, cardiovascular involvement (using echocardiography, ECG, and blood pressure monitoring), and microvascular abnormalities identified via nailfold capillaroscopy. Findings from this study may establish catestatin as a promising biomarker, paving the way for improved management and cardiovascular risk stratification in SSc patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Sclerosis Arm | – | –Patients with systemic sclerosis (n=35), assessed for disease activity, catestatin levels, cardiovascular involvement, and microvascular changes. |
| Control Arm | – | –Healthy controls (n=35), evaluated for serum catestatin levels to provide a baseline reference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will include 35 patients diagnosed with systemic sclerosis according to the 2013 ACR-EULAR classification criteria and 35 age- and sex-matched healthy controls without autoimmune or cardiovascular diseases. Patients must be over 18 years old, and both genders will be included. Controls will be recruited from hospital staff and volunteers. Exclusion criteria eliminate any confounding factors affecting serum catestatin, including other autoimmune diseases, comorbid cardiovascular conditions unrelated to SSc, diabetes, chronic kidney disease, and obesity.
Key inclusion criteria (2 listed)
- Patients diagnosed with systemic sclerosis according to 2013 ACR-EULAR classification criteria.
- Age >18 years.
Key exclusion criteria (3 listed)
- Other autoimmune disorders.
- Cardiovascular conditions not linked to systemic sclerosis.
- Comorbidities affecting catestatin metabolism (e.g., diabetes, chronic kidney disease, obesity).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in level of serum catestatin concentration in systemic sclerosis patients compared with healthy controls.
Time frame: baseline
Quantification of serum catestatin levels using ELISA, directly compared between the two study groups.
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 7 Oct 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Assiut University.
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 3 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 7 Oct 2025. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in level of serum catestatin concentration in systemic sclerosis patients compared with healthy controls. (time frame: baseline). 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 7 Oct 2025.