Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

NCT ID: NCT05911724

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-09-30

Brief Summary

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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

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* 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.

Conditions

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Stable Angina Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group I

60 Healthy Subjects.

Group I Healthy

Intervention Type OTHER

Healthy Subjects

Group II

60 Patients with Stable Angina on empagliflozin 10 mg once daily for 6 months before the beginning of the study.

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

Intervention Type DRUG

Group II: Stable Angina Patients

Group III

60 Patients with Heart Failure on empagliflozin 10 mg once daily for 6 months before the beginning of the study.

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

Intervention Type DRUG

Group III: Heart Failure Patients

Interventions

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Group I Healthy

Healthy Subjects

Intervention Type OTHER

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

Group II: Stable Angina Patients

Intervention Type DRUG

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

Group III: Heart Failure Patients

Intervention Type DRUG

Other Intervention Names

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Empa- CAD Empa-HF

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Damanhour University

OTHER

Sponsor Role lead

Responsible Party

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Rehab Werida

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ibtsam Khairat, Ass. Prof.

Role: STUDY_DIRECTOR

Tanta University

Ahmed A. El-Sherbeni, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Tanta University Hospital

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 30942129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24766981 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29066452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23847549 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18160340 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40413121 (View on PubMed)

Other Identifiers

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inflammatory biomarkers in CVD

Identifier Type: -

Identifier Source: org_study_id

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