Clinical trial NCT05911724: Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.
Official title: Diagnostic and Prognostic Roles of Inflammatory Biomarkers in Coronary Heart Disease and Heart Failure Patients Treated With Empagliflozin.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stable Angina
Heart Failure
Keywords: vaspin
visfatin
lipoprotein A
high-sensitivity C-reactive protein
sortilin
homocysteine
troponin I
fetuin A
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2023-06-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All Cause 30 day hosptial admission
timeFrame: 1 month
measure: All Cause 90 day hosptial admission
timeFrame: 3 months
measure: vaspin (ng/ml)
timeFrame: 1 month
measure: visfatin (ng/ml)
timeFrame: 1 month
measure: Sortillin (pg/ml)
timeFrame: 1 month
measure: Homocystien(umol/L)
timeFrame: 1 Month
measure: Troponin.I (ng/ml)
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: El-Gharbia
Study officials:
affiliation: Tanta University
name: Ibtsam Khairat, Ass. Prof.
role: STUDY_DIRECTOR
affiliation: Tanta University
name: Ahmed A. El-Sherbeni, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.