## Protocol Section
### Identification Module
**NCT ID:** NCT06426368

**Brief Title:** 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"

#### Organization Study ID Info
**ID:** ST2 in H.F patients
#### Organization
**Class:** OTHER
**Full Name:** Assiut University
### Status Module
#### Completion Date
**Date:** 2027-01-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Assiut University

#### Responsible Party

**Investigator Affiliation:** Assiut University

**Investigator Full Name:** Dalia Mohamed Hesham Ahmed Mohamed

**Investigator Title:** doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 .

### Conditions Module

**Conditions:**

- Heart Failure Patients

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%)

**Intervention Names:**

- Diagnostic Test: ST2

**Label:** Group I

#### Arm Group 2

**Description:** HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%)

**Intervention Names:**

- Diagnostic Test: ST2

**Label:** Group II

#### Arm Group 3

**Description:** HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%)

**Intervention Names:**

- Diagnostic Test: ST2

**Label:** Group III

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group I

- Group II

- Group III

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

**Name:** ST2

**Other Names:**

- BNP

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

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

**Measure:** To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome

**Time Frame:** Baseline

**Description:** Study value of BNP in prognosis and compare it with ST2

**Measure:** Evaluation of BNP and ST2 could have a potential role in prognosis.

**Time Frame:** Baseline

#### Secondary Outcomes

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

**Measure:** • Clinical Impact and Treatment Decision Support

**Time Frame:** Baseline

### Eligibility Module

**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 .

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** daliahesham1771993@gmail.com

**Name:** Dalia Hesham

**Phone:** 01149936172

**Role:** CONTACT

**Contact 2:**

**Name:** randa ahmed

**Phone:** 01003390690

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Assiut University

**Name:** Randa Ahmed

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Assiut University

**Name:** Hanan Omer

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Assiut University

**Name:** Yousra Mamdouh

**Role:** STUDY_DIRECTOR

### References Module

#### 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.

**PMID:** 11418557

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Intervention Browse Module - Browse Branches

- Abbrev: NaAg

- Name: Natriuretic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21935

- Name: Natriuretic Peptide, Brain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
