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NCT Number: NCT07209644

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 7, 2025
Registry last updated
Oct 7, 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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