Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.
NCT ID: NCT05911724
Last Updated: 2025-01-07
Study Results
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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COMPLETED
180 participants
OBSERVATIONAL
2023-03-01
2024-09-30
Brief Summary
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Detailed Description
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* 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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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group I
60 Healthy Subjects.
Group I Healthy
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
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
Group III: Heart Failure Patients
Interventions
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Group I Healthy
Healthy Subjects
CAD-Empagliflozin 10 mg once daily for 6 months before the beginning of the study
Group II: Stable Angina Patients
HF-Empagliflozin 10 mg once daily for 6 months before the beginning of the study
Group III: Heart Failure Patients
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Tanta University
OTHER
Damanhour University
OTHER
Responsible Party
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Rehab Werida
Associate Professor
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
Countries
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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.
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.
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.
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.
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.
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.
Other Identifiers
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inflammatory biomarkers in CVD
Identifier Type: -
Identifier Source: org_study_id
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