Catestatin as a Novel Biomarker for Cardiovascular and Microvascular Involvement in Systemic Sclerosis

Serum Catestatin in Systemic Sclerosis: Relations to Cardiovascular Involvement and Microvascular Alterations

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07209644

Enrollment

Registered

2025-10-07

Start date

2026-11-01

Completion date

2027-12-01

Last updated

2025-10-07

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

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosis

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients diagnosed with systemic sclerosis according to 2013 ACR-EULAR classification criteria. Age \>18 years.

Exclusion criteria

* Other autoimmune disorders. Cardiovascular conditions not linked to systemic sclerosis. Comorbidities affecting catestatin metabolism (e.g., diabetes, chronic kidney disease, obesity).

Design outcomes

Primary

Measure	Time frame	Description
change in level of serum catestatin concentration in systemic sclerosis patients compared with healthy controls.	baseline	Quantification of serum catestatin levels using ELISA, directly compared between the two study groups.

Outcome results