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CompletedNCT05911724Updated Jan 7, 2025

Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

An observational study in Stable Angina and Heart Failure, sponsored by Damanhour University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Damanhour University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
180
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Stable Angina
  • Heart Failure

Keywords

  • vaspin
  • visfatin
  • lipoprotein A
  • high-sensitivity C-reactive protein
  • sortilin
  • homocysteine
  • troponin I
  • fetuin A
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 180 is close to the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Damanhour University is the lead sponsor of 76 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • Group I

    60 Healthy Subjects.

    Other: Group I Healthy

  • 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 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

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

    Also known as: Empa- CAD

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

    Group III: Heart Failure Patients

    Also known as: Empa-HF

06

What researchers measure

Primary outcomes

  1. All Cause 30 day hosptial admission

    Number of patients admited to hospital during 1 month.

    Time frame: 1 month

  2. All Cause 90 day hosptial admission

    Number of patients admited to hospital during 3 month.

    Time frame: 3 months

  3. vaspin (ng/ml)

    vaspin blood concentration

    Time frame: 1 month

  4. visfatin (ng/ml)

    visfatin blood concentration

    Time frame: 1 month

  5. Sortillin (pg/ml)

    Sortillin blood concentration

    Time frame: 1 month

  6. Homocystien(umol/L)

    Homocystien blood concentration

    Time frame: 1 Month

  7. Troponin.I (ng/ml)

    Troponin.I blood concentration

    Time frame: 1 Month

07

Study locations

1 site
  • Tanta University Hospital
    Tanta, El-Gharbia 31527, Egypt
08

References and documents

Publications

  • Konig P, Mayer O, Bruthans J, Seidlerova J, Materankova M, Gelzinsky J, Rychecka M, Karnosova P, Wohlfahrt P, Cifkova R, Filipovsky J. The prognostic importance of subclinical heart failure in stable coronary heart disease patients. Acta Cardiol. 2020 Aug;75(4):329-336. doi: 10.1080/00015385.2019.1590958. Epub 2019 Apr 3. PubMed 30942129 ↗
  • Eisen A, Benderly M, Behar S, Goldbourt U, Haim M. Inflammation and future risk of symptomatic heart failure in patients with stable coronary artery disease. Am Heart J. 2014 May;167(5):707-14. doi: 10.1016/j.ahj.2014.01.008. Epub 2014 Feb 22. PubMed 24766981 ↗
  • Held C, White HD, Stewart RAH, Budaj A, Cannon CP, Hochman JS, Koenig W, Siegbahn A, Steg PG, Soffer J, Weaver WD, Ostlund O, Wallentin L; STABILITY Investigators. Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10):e005077. doi: 10.1161/JAHA.116.005077. PubMed 29066452 ↗
  • Papaioannou V, Pneumatikos I, Maglaveras N. Association of heart rate variability and inflammatory response in patients with cardiovascular diseases: current strengths and limitations. Front Physiol. 2013 Jul 10;4:174. doi: 10.3389/fphys.2013.00174. eCollection 2013. PubMed 23847549 ↗
  • Williams ES, Shah SJ, Ali S, Na BY, Schiller NB, Whooley MA. C-reactive protein, diastolic dysfunction, and risk of heart failure in patients with coronary disease: Heart and Soul Study. Eur J Heart Fail. 2008 Jan;10(1):63-9. doi: 10.1016/j.ejheart.2007.11.003. Epub 2007 Dec 21. PubMed 18160340 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05911724
Lead sponsor
Damanhour University
Collaborators
Tanta University
Responsible party
Rehab Werida (Associate Professor, Damanhour University) — Principal investigator
First posted
Jun 22, 2023
Start date
Mar 1, 2023
Primary completion
Sep 20, 2024
Completion
Sep 30, 2024
Last update
Jan 7, 2025

Study contacts

Ibtsam Khairat, Ass. Prof.
study director · Tanta University
Ahmed A. El-Sherbeni, Lecturer
principal investigator · Tanta University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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