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Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05911724
Enrollment
180
Registered
2023-06-22
Start date
2023-03-01
Completion date
2024-09-30
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Stable Angina

Keywords

vaspin, visfatin, lipoprotein A, high-sensitivity C-reactive protein, sortilin, homocysteine, troponin I, fetuin A

Brief summary

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.

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.

Interventions

OTHERGroup I Healthy

Healthy Subjects

DRUGCAD-Empagliflozin 10 mg once daily for 6 months before the beginning of the study

Group II: Stable Angina Patients

DRUGHF-Empagliflozin 10 mg once daily for 6 months before the beginning of the study

Group III: Heart Failure Patients

Sponsors

Tanta University
CollaboratorOTHER
Damanhour University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All Cause 30 day hosptial admission1 monthNumber of patients admited to hospital during 1 month.
All Cause 90 day hosptial admission3 monthsNumber of patients admited to hospital during 3 month.
vaspin (ng/ml)1 monthvaspin blood concentration
visfatin (ng/ml)1 monthvisfatin blood concentration
Sortillin (pg/ml)1 monthSortillin blood concentration
Homocystien(umol/L)1 MonthHomocystien blood concentration
Troponin.I (ng/ml)1 MonthTroponin.I blood concentration

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026