"The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"

Recruiting

• Conditions: 2 Drugs Are Statin and SGLT2i
• Interventions: Drug: Statin and SGLT2i

• Registration Number: NCT06520891
• Lead Sponsor: Fayoum University

Brief Summary

correlate the serum level of statin and SGLT2i when given as polytherapy with HPLC in ischemic heart failure patients and their laboratory tests (cholesterol, LDL, HDL and TG...)

Detailed Description

This is a prospective study that will carried out in Department of cardiology, Faculty of Medicine, Fayoum University during the period from 1 April 2024 to 1 Juley 2024. The study includes 90 Outpatients Clinic patients who met the inclusion criteria. Patients will provide written informed consent before involving in this study.

* we will split the 90 patients into three groups:

1. 30 patients will take statin.

2. 30 patients will take SGLT2i.

3. 30 patients will take both of statin and SGLT2i.

* By collecting their blood samples and calculate the serum level of statin by using HPLC and calculate plasma level of SGLT2i by using HPLC as baseline first then after three months to predict the effect of each drug to another one, we will follow their cholesterol, triglyceride, low density lipo-protein and high density lipo-protein and we will also inspect their adverse effects.

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-07-20
• Study First Submitted QC: 2024-07-20
• Study First Posted: 2024-07-25
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• we include patients established ischemic heart failure seen by a primary care provider to diagnose ischemic heart disease,
• They assessed the use of statin with SGLT2i.

Exclusion Criteria

• We exclude patients with

  1. liver dysfunction.
  2. renal dysfunction.
  3. fungal infection.
  4. coagulation disorder.
  5. Pts using drugs that interact with SGLT2i.
  6. patients that will refuse to be enrolled in the Study or refuse to write informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients has ischemic heart failure	Statin and SGLT2i	30 patients will take statin.
Patients has ischemic heart	Statin and SGLT2i	30 patients will take both of statin and SGLT2i.
Patients has heart disease	Statin and SGLT2i	30 patients will take SGLT2i.

Primary Outcome Measures

Name	Time	Method
The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease	Three months of follow up	correlate the serum level of statin and SGLT2i when given as polytherapy with ECG in ischemic heart failure patients and their laboratory tests (cholesterol, LDL, HDL and TG...)

Trial Locations

Locations (1)

Asmaa mohamed abdelkader; 🇪🇬 El-Fayum, El Fayoum, Egypt