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Not yet recruiting NCT06426368

Soluble ST2 in Patients With Heart Failure"

Observational Heart Failure Patients

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
The protocol lists: ST2.
Who it may be relevant to
Registry conditions: Heart Failure Patients. Basic parameters: 18 years — 80 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

" Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of Patients With Heart Failure"

Overview

1. The aim of this study was to explore the relationship between peripheral circulating serum soluble suppression of tumorigenicity-2 (sST2) levels and inflammatory biomarkers in patients with heart failure 2. Additive role of sST2 to NPs in of heart failure patients

Detailed description

Heart failure (HF), a complex and heterogeneous medical syndrome characterized by structural and functional cardiac abnormalities and hemodynamic disruptions, represents the end-stage manifestation of numerous cardiovascular disorders . HF is categorized into three groups based on the measurement of the left ventricular (LV) ejection fraction (LVEF) according to the European Society of Cardiology (ESC) Guidelines issued in 2021: HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%), HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%), and HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) .

Quantifying concentrations of circulating biomarkers plays a major role in most cardiovascular (CV) diseases, including (HF) .

An ideal biomarker in HF should be measured non-invasively and at low cost, highly sensitive to allow for the early detection of the disease .

N-terminal pro-B-type natriuretic peptide (NT-proBNP) released by cardiac muscle tissue in response to abnormal volume load is an established indicator for the diagnosis and prognosis of HF .

However, there are important limitations to natriuretic peptide (NP) testing in HF .

Soluble suppression of tumorigenicity-2 (sST2) is the circulating form of the interleukin-33 membrane receptor released in response to inflammation, fibrosis in various organs, and myocardium stress .

Soluble (s)ST2 has been proposed as a useful biomarker for heart failure (HF) patient management. Myocardial damage or mechanical stress stimulate sST2 release. ST2 competes with a membrane bound receptor (ST2 ligand, or ST2L) for interleukin-33 (IL-33) binding, inhibiting the effects induced by the ST2L/IL-33 interaction so that excessive sST2 may contribute to myocardial fibrosis and ventricular remodelling.

So biomarkers such as NT-proBNP and sST2 could potentially be used as surrogates for clinical outcomes in patients with HF and may be useful in monitoring disease progression and assessing the response to therapy .

Interventions

  • Diagnostic test ST2
    ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure

Primary outcome measures

  • To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome [Time frame: Baseline]
  • Evaluation of BNP and ST2 could have a potential role in prognosis. [Time frame: Baseline]
Secondary outcome measures (1)
  • • Clinical Impact and Treatment Decision Support [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • patients 18-80 years.
  • Both sexes will be included.
  • including signs and symptoms of HF (e.g., elevated jugular venous pressure and altered apical beat position), altered LVEF (< 40%; 40%-49%; ≥ 50%)

Exclusion criteria

  • Patients <18 years
  • Patients with documented evidence of cardiogenic shock .
  • Patients with Acute coronary syndrome within 30 days.
  • chronic kidney disease patients with glomerular filtration rate < 30
  • Patients with interstitial pulmonary fibrosis .

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

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Purdy GE, Payne SM. The SHI-3 iron transport island of Shigella boydii 0-1392 carries the genes for aerobactin synthesis and transport. J Bacteriol. 2001 Jul;183(14):4176-82. doi: 10.1128/JB.183.14.4176-4182.2001. PMID 11418557

Identifiers

NCT: NCT06426368 · ST2 in H.F patients

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗