Current partner codePEPTIDESDE
NCT06426368·Not applicable·OBSERVATIONAL

Soluble ST2 in Patients With Heart Failure"

Status

Not yet recruiting

Phase

Not applicable

Enrollment

100

Locations

0

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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

Treatment arms and agents.

DIAGNOSTIC_TEST

ST2

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

Timeline

From registration to results.

  1. First posted

    May 23, 2024

  2. Study start

    Jul 1, 2024

  3. Primary completion

    Jul 1, 2026

  4. Study completion

    Jan 1, 2027

  5. Results posted

    Not reported

  6. Registry updated

    May 23, 2024

Outcomes

What the study measures.

Primary outcomes

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

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

• 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
Not reported

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 .

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

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Put the record in context.

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