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

F

Fayoum University

Status

Enrolling

Conditions

2 Drugs Are Statin and SGLT2i

Treatments

Drug: Statin and SGLT2i

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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...)

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

Patients has ischemic heart failure
Description:
30 patients will take statin.
Treatment:
Drug: Statin and SGLT2i
Patients has ischemic heart
Description:
30 patients will take both of statin and SGLT2i.
Treatment:
Drug: Statin and SGLT2i
Patients has heart disease
Description:
30 patients will take SGLT2i.
Treatment:
Drug: Statin and SGLT2i

Trial contacts and locations

1

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Central trial contact

Raghda Roshdy; Marwa Kamal

Data sourced from clinicaltrials.gov

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