CClinicalTrials.gg
Sign In
RecruitingNCT06520891Updated Sep 11, 2025

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

An observational study in 2 Drugs Are Statin and SGLT2i, sponsored by Fayoum University. Recruiting at 1 site in Egypt. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Fayoum University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
90
Ages
50 Years to 80 Years
Sex
All
01

Study 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...)

Read the 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.
02

Conditions studied

  • 2 Drugs Are Statin and SGLT2i
03

In context

Lead sponsor

Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
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)

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

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.
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients has ischemic heart failure

    30 patients will take statin.

    Drug: Statin and SGLT2i

  • Patients has ischemic heart

    30 patients will take both of statin and SGLT2i.

    Drug: Statin and SGLT2i

  • Patients has heart disease

    30 patients will take SGLT2i.

    Drug: Statin and SGLT2i

Interventions

  • DrugStatin and SGLT2i

    Statin as atrovastatin SGLT2i as dapagliflozin

06

What researchers measure

Primary outcomes

  1. 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...)

    Time frame: Three months of follow up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — After ending the study, I will share it in magazin with other researchers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06520891
Lead sponsor
Fayoum University
Responsible party
Asmaa Mohamed Abdelkader ("The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease", Fayoum University) — Principal investigator
First posted
Jul 25, 2024
Start date
Jun 1, 2024
Primary completion
Nov 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Sep 11, 2025

Study contacts

Raghda Roshdy
Contact
Raghda.hussien@pharm.bsu.edu.eg
01010647666
Marwa Kamal
Contact
mka05@fayoum.edu.eg
01067789982

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Fayoum University

Start the discussion