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

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...)

Study Overview

• Status: Recruiting
• Conditions: 2 Drugs Are Statin and SGLT2i
• Intervention / Treatment: Drug: Statin and SGLT2i

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 Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

• Study Contact: Name: Raghda Roshdy; Phone Number: 01010647666; Email: Raghda.hussien@pharm.bsu.edu.eg
• Study Contact Backup: Name: Marwa Kamal; Phone Number: 01067789982; Email: mka05@fayoum.edu.eg

Study Locations

• Egypt
  • Faiyum Governorate
    • Al Fayyum, Faiyum Governorate, Egypt
      • Recruiting
      • Asmaa mohamed abdelkader
      • Contact: Raghda Roshdy, Assisstant professor; Phone Number: 01010647666; Email: Raghda.hussien@pharm.bsu.edu.eg
      • Contact: Marwa Kamal, Assisstant professor; Phone Number: 01067789982; Email: mka05@fayoum.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

the health care provider asks about patient's symptoms which may experience:

• Chest pain, especially after physical exertion
• Dizziness or fainting
• Heart palpitations, which may feel like your heart fluttering or skipping beats
• Shortness of breath

• Swelling in your feet or ankles

  • brain natriuretic peptide (BNP) with 70% sensitivity and 99% specificity and N-terminal proBNP (NT-proBNP) with 99% sensitivity and 85% specificity which are Other HF-specific laboratory tests (especially in patients with a high possibility of heart failure) included. (18)
  • chest X-ray, transthoracic echocardiography (TTE), computerized tomography (CT) scans and magnetic resonance imaging (MRI) also other diagnostic tests for HF. (19)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients has ischemic heart failure; 30 patients will take statin.	Drug: Statin and SGLT2i; Statin as atrovastatin SGLT2i as dapagliflozin
Patients has ischemic heart; 30 patients will take both of statin and SGLT2i.	Drug: Statin and SGLT2i; Statin as atrovastatin SGLT2i as dapagliflozin
Patients has heart disease; 30 patients will take SGLT2i.	Drug: Statin and SGLT2i; Statin as atrovastatin SGLT2i as dapagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease	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...)	Three months of follow up

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: July 20, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: M716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After ending the study, I will share it in magazin with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No