Soluble ST2 in Patients With Heart Failure"

" Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of 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

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure Patients
• Intervention / Treatment: Diagnostic test: ST2

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 .

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Dalia Hesham; Phone Number: 01149936172; Email: daliahesham1771993@gmail.com
• Study Contact Backup: Name: randa ahmed; Phone Number: 01003390690

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%)	Diagnostic test: ST2; ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure; Other Names: BNP
Group II; HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%)	Diagnostic test: ST2; ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure; Other Names: BNP
Group III; HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%)	Diagnostic test: ST2; ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure; Other Names: BNP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome	Study ST2 level in heart failure patients and correlate results with clinical data and other inflammatory biomarker	Baseline
Evaluation of BNP and ST2 could have a potential role in prognosis.	Study value of BNP in prognosis and compare it with ST2	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Clinical Impact and Treatment Decision Support	Evaluate ST2 as a novel biomarker which provide risk stratification of patients with acute and chronic HF beyond BNPs	Baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Randa Ahmed, Assiut University; Study Director: Hanan Omer, Assiut University; Study Director: Yousra Mamdouh, Assiut University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ST2 in H.F patients

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No