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Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

D

Damanhour University

Status

Completed

Conditions

Stable Angina
Heart Failure

Treatments

Drug: HF-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
Other: Group I Healthy

Study type

Observational

Funder types

Other

Identifiers

NCT05911724
inflammatory biomarkers in CVD

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

180 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Naglaa Khedr, Prof.; Rehab H Werida, Ass. Prof.

Data sourced from clinicaltrials.gov

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