"The Effect of The Combination Therapy of Statin and SGLT... | NCT06520891

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

NCT06520891

Sponsor

Fayoum University

Status

Recruiting

Last Update Posted

Sep 11, 2025Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

2 Drugs Are Statin and SGLT2i

Interventions

Statin and SGLT2i

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Nov 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Jul 20, 2024

First Submission Date that Met QC Criteria

Jul 20, 2024

First Posted Date

Jul 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2025

Last Update Posted Date

Sep 11, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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...)

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Statin and SGLT2i	Drug	Statin as atrovastatin SGLT2i as dapagliflozin	Patients has heart disease Patients has ischemic heart Patients has ischemic heart failure

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Raghda Roshdy	Contact	01010647666		Raghda.hussien@pharm.bsu.edu.eg
Marwa Kamal	Contact	01067789982		mka05@fayoum.edu.eg

Facility	Status	City	State	ZIP	Country	Contacts
Asmaa mohamed abdelkader	Recruiting	Al Fayyum	Faiyum Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

After ending the study, I will share it in magazin with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Ancestor Terms

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.