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Not yet recruiting NCT07209644

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

Observational Systemic Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Systemic Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • change in level of serum catestatin concentration in systemic sclerosis patients compared with healthy controls. [Time frame: baseline]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07209644 · Serum Catestatin

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗