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OpenTrials
Completed

NCT Number: NCT05911724

Association Between Inflammatory Biomarkers in CVD Patients on 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.

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Key information

Conditions

Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Heart Failure Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group I Healthy

Other

Healthy Subjects

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

Drug

Group II: Stable Angina Patients

Other names: Empa- CAD

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

Drug

Group III: Heart Failure Patients

Other names: Empa-HF

Primary outcomes

  1. All Cause 30 day hosptial admission

    Time frame: 1 month

    Number of patients admited to hospital during 1 month.

  2. All Cause 90 day hosptial admission

    Time frame: 3 months

    Number of patients admited to hospital during 3 month.

  3. vaspin (ng/ml)

    Time frame: 1 month

    vaspin blood concentration

  4. visfatin (ng/ml)

    Time frame: 1 month

    visfatin blood concentration

  5. Sortillin (pg/ml)

    Time frame: 1 month

    Sortillin blood concentration

  6. Homocystien(umol/L)

    Time frame: 1 Month

    Homocystien blood concentration

  7. Troponin.I (ng/ml)

    Time frame: 1 Month

    Troponin.I blood concentration

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2023
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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