Clinical trial NCT06426368: Soluble ST2 in Patients With Heart Failure"
Official title: " Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of Patients With Heart Failure"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted at Chemistry unit of Clinical Pathology Department and Cardiovascular Department, Assiut University Hospitals, Assiut University, Egypt Heart failure patients will be classified according to NYHA classification

Brief summary: 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 .

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 .

Primary outcomes:
measure: To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome
timeFrame: Baseline
measure: Evaluation of BNP and ST2 could have a potential role in prognosis.
timeFrame: Baseline
Secondary outcomes:
measure: • Clinical Impact and Treatment Decision Support
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Randa Ahmed
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Hanan Omer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Yousra Mamdouh
role: STUDY_DIRECTOR
References:
citation: 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.