Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

NCT05911724 | Completed

• 1 other identifier: inflammatory biomarkers in CVD
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Angina; Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (7)

• All Cause 30 day hosptial admission

  Number of patients admited to hospital during 1 month.

  1 month

• All Cause 90 day hosptial admission

  Number of patients admited to hospital during 3 month.

  3 months

• vaspin (ng/ml)

  vaspin blood concentration

  1 month

• visfatin (ng/ml)

  visfatin blood concentration

  1 month

• Sortillin (pg/ml)

  Sortillin blood concentration

  1 month

• Homocystien(umol/L)

  Homocystien blood concentration

  1 Month

• Troponin.I (ng/ml)

  Troponin.I blood concentration

  1 Month

Study Arms (3)

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

Group I Healthy OTHER

Healthy Subjects

Group I

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

Group II: Stable Angina Patients

Also known as: Empa- CAD

Group II

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

Group III: Heart Failure Patients

Also known as: Empa-HF

Group III

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (6)

• 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.

  PMID: 30942129 BACKGROUND

• 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.

  PMID: 24766981 BACKGROUND

• 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.

  PMID: 29066452 BACKGROUND

• 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.

  PMID: 23847549 BACKGROUND

• 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.

  PMID: 18160340 BACKGROUND

• El-Sherbeni AA, Khedr NF, Khairat I, Werida RH. Diagnostic and Prognostic Roles of Inflammatory Biomarkers in Patients With Coronary Heart Disease and Heart Failure Treated With Empagliflozin. Clin Ther. 2025 Aug;47(8):e1-e11. doi: 10.1016/j.clinthera.2025.04.019. Epub 2025 May 24.

  PMID: 40413121 DERIVED

MeSH Terms

Conditions

Angina, Stable; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Officials

• Ibtsam Khairat, Ass. Prof.

  Tanta University

  STUDY DIRECTOR

• Ahmed A. El-Sherbeni, Lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 22, 2023
• Study Start: March 1, 2023
• Primary Completion: September 20, 2024
• Study Completion: September 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)