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

NCT ID: NCT06520891

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

2 Drugs Are Statin and SGLT2i

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients has ischemic heart failure

30 patients will take statin.

Statin and SGLT2i

Intervention Type DRUG

Statin as atrovastatin SGLT2i as dapagliflozin

Patients has ischemic heart

30 patients will take both of statin and SGLT2i.

Statin and SGLT2i

Intervention Type DRUG

Statin as atrovastatin SGLT2i as dapagliflozin

Patients has heart disease

30 patients will take SGLT2i.

Statin and SGLT2i

Intervention Type DRUG

Statin as atrovastatin SGLT2i as dapagliflozin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Statin and SGLT2i

Statin as atrovastatin SGLT2i as dapagliflozin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fayoum University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Asmaa Mohamed Abdelkader

"The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease"

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asmaa mohamed abdelkader

Al Fayyum, Faiyum Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Raghda Roshdy

Role: CONTACT

01010647666

Marwa Kamal

Role: CONTACT

01067789982

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Raghda Roshdy, Assisstant professor

Role: primary

01010647666

Marwa Kamal, Assisstant professor

Role: backup

01067789982

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M716

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effective Dose of Statin Post PCI
NCT04923152 COMPLETED NA
Familial Atherosclerosis Treatment Study
NCT00000512 COMPLETED PHASE3