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

NCT06585761 | Recruiting DMC FDA Device

• 1 other identifier: KFSIRB200-128
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention

  At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL.

  1 year

• clinical examination for the presence and extent of improvement in signs and symptoms

  Clinical examination depending on NYHA classification of the participants

  1 year

Secondary Outcomes (2)

• measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention

  1 year

• Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention

  1 year

Other Outcomes (1)

• measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers in heart failure patients before and after the intervention

  1 year

Study Arms (2)

pre-SGLT2I group

patients with heart failure newly introduced to one of SGLT2I members

Device: echo cardiogram

Post-SGLT2I group

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

Drug: SGLT2 inhibitor; Device: echo cardiogram

Interventions

SGLT2 inhibitor DRUG

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

Also known as: empagliflozin, Dapagliflozin

Post-SGLT2I group

echo cardiogram DEVICE

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

Post-SGLT2I group; pre-SGLT2I group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

participants who are candidates for SGLT2i and will be recruited from Cardiology Department, Kafrelshiekh University Hospital.

You may qualify if:

• Patients aged more than 18 years old.
• Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)
• 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.
• All patients signed the informed consent.

You may not qualify if:

• 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.
• Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.
• Female patients during pregnancy or lactation
• Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR \<20 mL/min/1.73 m²).
• Individuals suffering from verbal communication disorders or psychic cognitive impairment.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University Hospital

Kafr ash Shaykh, 33516, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum sample

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium-Glucose Transporter 2 Inhibitors; empagliflozin; dapagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Nada Nabil Mohammed Elsalhey, Bsc

  clinical pharmacy department, kafrelsheikh university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada Nabil mohammed elsalhey, BSC

CONTACT

+201062787805; nada.nabil@pharm.kfs.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 5, 2024
• Study Start: February 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

EG (1)