Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients

NCT ID: NCT06585761

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-15
• Study Completion Date: 2025-06-30

Brief Summary

The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

pre-SGLT2I group

patients with heart failure newly introduced to one of SGLT2I members

echo cardiogram

Intervention Type: DEVICE

the patients are subjected to ECHO to determine their EF prior to and post the study

Post-SGLT2I group

patients with heart failure on one of SGLT2I members for at least 2 months

SGLT2 inhibitor

Intervention Type: DRUG

patients with HF are subjected to regular dose of SGLT2I member according to patient status.

echo cardiogram

Intervention Type: DEVICE

the patients are subjected to ECHO to determine their EF prior to and post the study

Interventions

SGLT2 inhibitor

patients with HF are subjected to regular dose of SGLT2I member according to patient status.

Intervention Type: DRUG

echo cardiogram

the patients are subjected to ECHO to determine their EF prior to and post the study

Intervention Type: DEVICE

Other Intervention Names

empagliflozin, Dapagliflozin

Eligibility Criteria

Inclusion Criteria

1. Patients aged more than 18 years old.

2. Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)

3. Patients are on standard therapy for management of HF (according to AHA/ACC/HFSA Guideline for the Management of Heart Failure2022)21 such as:

• ACEi (angiotensin converting enzyme inhibitor)
• ARB (angiotensin receptor blocker)
• ARNI in place of ACEi OR ARB
• Beta blocker
• (MRA) Mineralocorticoid receptor antagonists
• Diuretics as needed.

4. All patients signed the informed consent.

Exclusion Criteria

1. Patients suffering from conditions like acute CVS illness and severe sepsis that raise inflammatory markers and may lead to cardiac dysfunction as opposed to heart failure.

2. Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.

3. Female patients during pregnancy or lactation

4. Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR <20 mL/min/1.73 m²).

5. Individuals suffering from verbal communication disorders or psychic cognitive impairment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Nada Nabil Elsalhey

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nada Nabil Mohammed Elsalhey, Bsc

Role: PRINCIPAL_INVESTIGATOR

clinical pharmacy department, kafrelsheikh university

Locations

Kafrelsheikh University Hospital

Kafr ash Shaykh, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nada Nabil mohammed elsalhey, BSC

Role: CONTACT

nada.nabil@pharm.kfs.edu.eg

+201062787805

Facility Contacts

Nada Nabil Mohammed Elsalhey, Bsc

Role: primary

nada.nabil@pharm.kfs.edu.eg

01062787805

Other Identifiers

KFSIRB200-128

Identifier Type: -

Identifier Source: org_study_id