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Stable AnginaNCT05911724

Association Between Inflammatory Biomarkers in CVD Patients on Empagliflozin.

An observational study of Stable Angina and Heart Failure, run by Damanhour University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stable Angina, Heart Failure
What is being tested?
Group I Healthy, CAD-Empagliflozin 10 mg once daily for 6 months before the beginning of the study and HF-Empagliflozin 10 mg once daily for 6 months before the beginning of the study
How many people
180 participants
Where
1 siteEgypt
Study dates
1 Mar 2023to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Tanta University Hospital

    Tanta, El-Gharbia, 31527

Other trials in Egypt

About this study

Official title: Diagnostic and Prognostic Roles of Inflammatory Biomarkers in Coronary Heart Disease and Heart Failure Patients Treated With Empagliflozin.

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.

Read the 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.
Being tested
Group I Healthy, CAD-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
Keywords
vaspin, visfatin, lipoprotein A, high-sensitivity C-reactive protein, sortilin, homocysteine, troponin I, fetuin A
Medical subject headings
Angina, Stable, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group I HealthyOther

    Healthy Subjects

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

    Also called Empa- CAD

    Group II: Stable Angina Patients

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

    Also called Empa-HF

    Group III: Heart Failure Patients

Study groups in NCT05911724
Study groupRoleWhat they receive
Group I60 Healthy Subjects.
Receives: Other: Group I Healthy
Group II60 Patients with Stable Angina on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
Receives: Drug: CAD-Empagliflozin 10 mg once daily for 6 months before the beginning of the study
Group III60 Patients with Heart Failure on empagliflozin 10 mg once daily for 6 months before the beginning of the study.
Receives: Drug: HF-Empagliflozin 10 mg once daily for 6 months before the beginning of the study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cause 30 day hosptial admission

    Number of patients admited to hospital during 1 month.

    Measured: 1 month

  2. All Cause 90 day hosptial admission

    Number of patients admited to hospital during 3 month.

    Measured: 3 months

  3. vaspin (ng/ml)

    vaspin blood concentration

    Measured: 1 month

  4. visfatin (ng/ml)

    visfatin blood concentration

    Measured: 1 month

  5. Sortillin (pg/ml)

    Sortillin blood concentration

    Measured: 1 month

  6. Homocystien(umol/L)

    Homocystien blood concentration

    Measured: 1 Month

  7. Troponin.I (ng/ml)

    Troponin.I blood concentration

    Measured: 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start1 Mar 2023
  3. Primary completion20 Sep 2024
  4. Study completion30 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05911724
Sponsor's protocol ID
inflammatory biomarkers in CVD
Status last verified
Jan 2025
First submitted
10 Jun 2023
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30942129

  • 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.

    PubMed 24766981

  • 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.

    PubMed 29066452

  • 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.

    PubMed 23847549

  • 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.

    PubMed 18160340

  • 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.

    PubMed 40413121

Questions about this trial

What is this clinical trial studying?

An observational study of Stable Angina and Heart Failure, run by Damanhour University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause 30 day hosptial admission (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05911724, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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