Heart Failure PatientsNCT06426368
Soluble ST2 in Patients With Heart Failure"
An observational study of Heart Failure Patients, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure Patients
- What is being tested?
- ST2
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- 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
Who may be able to join
- 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%)
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
randa ahmed contact
About this study
Official title: " Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of Patients With Heart Failure"
- 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
- Additive role of sST2 to NPs in of heart failure patients
Read the 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
- Heart Failure Patients
- Being tested
- ST2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST2Diagnostic test
Also called BNP
ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure
| Study group | Role | What they receive |
|---|---|---|
| Group I | HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%) Receives: Diagnostic Test: ST2 | |
| Group II | HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%) Receives: Diagnostic Test: ST2 | |
| Group III | HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) Receives: Diagnostic Test: ST2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Evaluation of BNP and ST2 could have a potential role in prognosis.
Study value of BNP in prognosis and compare it with ST2
Measured: Baseline
Secondary outcomes (1)
• 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Mohamed Hesham Ahmed Mohamed, Assiut University
- Investigators
- Randa Ahmed, Study director, Assiut UniversityHanan Omer, Study director, Assiut UniversityYousra Mamdouh, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426368
- Sponsor's protocol ID
- ST2 in H.F patients
- Status last verified
- May 2024
- First submitted
- 12 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 11418557
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of Patients With Heart Failure"
- ClinicalTrials.gov ID
- NCT06426368
- Acronym / sponsor ID
- ST2 in H.F patients
- Conditions
- Heart Failure Patients
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- 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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: ST2HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%) |
| Group II | – | Diagnostic Test: ST2HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%) |
| Group III | – | Diagnostic Test: ST2HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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%)
Key exclusion criteria (5 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST2Also: BNPELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure | Diagnostic test | Group I, Group II, Group III |
Primary outcome
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
1 secondary outcome
• Clinical Impact and Treatment Decision Support
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 11418557Purdy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
randa ahmed contact
Randa Ahmed study director
Assiut University
Hanan Omer study director
Assiut University
Yousra Mamdouh study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure Patients, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalia Hesham (01149936172, daliahesham1771993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06426368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024; AzTrials last refreshed its copy on 2 Nov 2026.