NCT06426368

Brief Summary

  1. 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. 2.Additive role of sST2 to NPs in of heart failure patients

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jul 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Jan 2027

First Submitted

Initial submission to the registry

May 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 12, 2024

Last Update Submit

May 17, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • • Clinical Impact and Treatment Decision Support

    Baseline

Study Arms (3)

Group I

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

Diagnostic Test: ST2

Group II

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

Diagnostic Test: ST2

Group III

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

Diagnostic Test: ST2

Interventions

ST2DIAGNOSTIC_TEST

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

Also known as: BNP
Group IGroup IIGroup III

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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%)

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 11418557BACKGROUND

Study Officials

  • Randa Ahmed

    Assiut University

    STUDY DIRECTOR
  • Hanan Omer

    Assiut University

    STUDY DIRECTOR
  • Yousra Mamdouh

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

randa ahmed

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

May 12, 2024

First Posted

May 23, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 23, 2024

Record last verified: 2024-05