Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

January 6, 2025 updated by: Rehab Werida, Damanhour University

Diagnostic and Prognostic Roles of Inflammatory Biomarkers in Coronary Heart Disease and Heart Failure Patients Treated With Empagliflozin.

The association of novel inflammatory biomarkers with cardiovascular diseases is still obscure. The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission. Methods: We enrolled a total of 120 patients with HF, asymptomatic CAD and 60 healthy controls (HC) without cardiovascular diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • The present study aimed to investigate the relationship of various inflammatory biomarkers with the existence as well as the extent of heart failure (HF) and coronary artery disease (CAD), suggesting a link between inflammation and cardiovascular diseases and all-cause 30- and -90 day of hospital readmission in patients on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
  • We enrolled a total of 60 patients with HF, 60 asymptomatic CAD patients and 60 healthy controls (HC) without cardiovascular diseases.

Group I: 60 Healthy Subjects. Group II: 60 Patients with Stable Angina (asymptomatic CAD). Group III: 60 Patients with Heart Failure.

  • Clinical parameters, glycemic and lipid profile, vaspin, visfatin, high-sensitivity C-reactive protein, sortilin, homocysteine, troponin I, fetuin A and lipoprotein A levels were assayed.
  • Patients will be followed up to assess all-cause 30- and -90 day of hospital readmission.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Group I: 60 Healthy Subjects. Group II: 60 Patients with Stable Angina (asyptomatic CAD), on empagliflozin 10 mg once daily for 6 months before the beginning of the study.

Group III: 60 Patients with Heart Failure, on empagliflozin 10 mg once daily for 6 months before the beginning of the study.

Description

Inclusion Criteria:

  • Either sex, aged 18 years or older.
  • new-onset AHF or acute decompensation of chronic HF,
  • CAD (including previous myocardial infarction, previous percutaneous or surgical coronary revascularization, or angiographic evidence that one or more major coronary arteries had narrowed by 50% or more).
  • On empagliflozin 10 mg once daily for 6 months before the beginning of the study.

Exclusion Criteria:

  • severe liver/
  • kidney dysfunction;
  • severe systemic disease (such as the diseases of respiratory system/ digestive system/ nervous system etc.);
  • malignant tumor;
  • acute/ chronic infectious diseases;
  • autoimmune disease or connective tissue disease;
  • major trauma or surgical operation over the past three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
60 Healthy Subjects.
Other: Group I Healthy
Healthy Subjects
Group II
60 Patients with Stable Angina on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
Drug: CAD-Empagliflozin 10 mg once daily for 6 months before the beginning of the study
Group II: Stable Angina Patients
Other Names:
  • Empa- CAD
Group III
60 Patients with Heart Failure on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
Drug: HF-Empagliflozin 10 mg once daily for 6 months before the beginning of the study
Group III: Heart Failure Patients
Other Names:
  • Empa-HF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause 30 day hosptial admission
Time Frame: 1 month
Number of patients admited to hospital during 1 month.
1 month
All Cause 90 day hosptial admission
Time Frame: 3 months
Number of patients admited to hospital during 3 month.
3 months
vaspin (ng/ml)
Time Frame: 1 month
vaspin blood concentration
1 month
visfatin (ng/ml)
Time Frame: 1 month
visfatin blood concentration
1 month
Sortillin (pg/ml)
Time Frame: 1 month
Sortillin blood concentration
1 month
Homocystien(umol/L)
Time Frame: 1 Month
Homocystien blood concentration
1 Month
Troponin.I (ng/ml)
Time Frame: 1 Month
Troponin.I blood concentration
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Tanta University

Investigators

  • Study Director: Ibtsam Khairat, Ass. Prof., Tanta University
  • Principal Investigator: Ahmed A. El-Sherbeni, Lecturer, Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

June 10, 2023

First Submitted That Met QC Criteria

June 10, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • inflammatory biomarkers in CVD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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