Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

Completed

• Conditions: Heart Failure; Stable Angina
• Interventions: Other: Group I; Other: Group III; Other: Group II; Other: Group I Healthy; Drug: CAD-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

• Registration Number: NCT05911724
• Lead Sponsor: Damanhour University

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-06-10
• Study First Posted: 2023-06-22
• Primary Completion: 2024-09-20
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	Group I	60 Healthy Subjects.
Group III	Group III	60 Patients with Heart Failure.
Group II	Group II	60 Patients with Stable Angina.
Group I	Group I Healthy	60 Healthy Subjects.
Group II	CAD-Empagliflozin 10 mg once daily for 6 months before the beginning of the study	60 Patients with Stable Angina on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
Group III	HF-Empagliflozin 10 mg once daily for 6 months before the beginning of the study	60 Patients with Heart Failure on empagliflozin 10 mg once daily for 6 months before the beginning of the study.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, El-Gharbia, Egypt