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NCT Number: NCT06426368

Soluble ST2 in Patients With Heart Failure"

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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 .

Who can participate

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

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 .

Treatment and study plan

ST2

Diagnostic Test

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

Other names: BNP

Primary outcomes

  1. To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome

    Time frame: Baseline

    Study ST2 level in heart failure patients and correlate results with clinical data and other inflammatory biomarker

  2. Evaluation of BNP and ST2 could have a potential role in prognosis.

    Time frame: Baseline

    Study value of BNP in prognosis and compare it with ST2

Secondary outcomes

  1. • Clinical Impact and Treatment Decision Support

    Time frame: Baseline

    Evaluate ST2 as a novel biomarker which provide risk stratification of patients with acute and chronic HF beyond BNPs

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Hesham

CONTACT

[email protected]

01149936172

randa ahmed

CONTACT

01003390690

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 23, 2024
Registry last updated
May 23, 2024

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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