Association Between Inflammatory Biomarkers and LV Function in Patients With CVD

Heart Failure Clinical Trial

Official title:

Prognostic Significance of Inflammatory Biomarkers and LV Functionin Patients With Coronary Heart Disease and Heart Failure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05911724
• Other study ID #: inflammatory biomarkers in CVD
• Status: Completed
• Start date: March 10, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: September 1, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

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.

Related Conditions & MeSH terms

• Angina, Stable
• Heart Failure
• Stable Angina

Intervention

Other:
• Group I
Healthy Subjects
• Group II
Stable Angina Patients
• Group III
Heart Failure Patients

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	El-Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause 30 day hosptial admission	Number of patients admited to hospital during 1 month.	1 month
Primary	All Cause 90 day hosptial admission	Number of patients admited to hospital during 3 month.	3 months
Primary	vaspin (ng/ml)	vaspin blood concentration	1 month
Primary	visfatin (ng/ml)	visfatin blood concentration	1 month
Primary	Sortillin (pg/ml)	Sortillin blood concentration	1 month
Primary	Homocystien(umol/L)	Homocystien blood concentration	1 Month
Primary	Troponin.I (ng/ml)	Troponin.I blood concentration	1 Month