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Recruiting NCT06520891

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

Observational 2 Drugs Are Statin and SGLT2i

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Statin and SGLT2i.
Who it may be relevant to
Registry conditions: 2 Drugs Are Statin and SGLT2i. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Drug Statin and SGLT2i
    Statin as atrovastatin SGLT2i as dapagliflozin

Primary outcome measures

  • The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease [Time frame: Three months of follow up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Egypt · 1 center
  • Asmaa mohamed abdelkader — Al Fayyum

Identifiers

NCT: NCT06520891 · M716

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗