2 Drugs Are Statin and SGLT2iNCT06520891
"The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"
An observational study of 2 Drugs Are Statin and SGLT2i, run by Fayoum University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- 2 Drugs Are Statin and SGLT2i
- What is being tested?
- Statin and SGLT2i
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Adult, Older 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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Asmaa mohamed abdelkader
Al Fayyum, Faiyum Governorate
Raghda Roshdy, Assisstant professor, 01010647666, Raghda.hussien@pharm.bsu.edu.eg
Marwa Kamal, Assisstant professor, 01067789982, mka05@fayoum.edu.eg
About this study
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:
- 30 patients will take statin.
- 30 patients will take SGLT2i.
- 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
- 2 Drugs Are Statin and SGLT2i
- Being tested
- Statin and SGLT2i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Statin and SGLT2iDrug
Statin as atrovastatin SGLT2i as dapagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Patients has ischemic heart failure | 30 patients will take statin. Receives: Drug: Statin and SGLT2i | |
| Patients has ischemic heart | 30 patients will take both of statin and SGLT2i. Receives: Drug: Statin and SGLT2i | |
| Patients has heart disease | 30 patients will take SGLT2i. Receives: Drug: Statin and SGLT2i |
What is being measured
The primary outcome is the main question the study is designed to answer.
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...)
Measured: Three months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jun 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2 Drugs Are Statin and SGLT2iStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohamed Abdelkader, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520891
- Sponsor's protocol ID
- M716
- Status last verified
- Sep 2025
- First submitted
- 20 Jul 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After ending the study, I will share it in magazin with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of The Combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart Disease"
- ClinicalTrials.gov ID
- NCT06520891
- Acronym / sponsor ID
- M716
- Conditions
- 2 Drugs Are Statin and SGLT2i
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 30 patients will take statin.
- 30 patients will take SGLT2i.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients has ischemic heart failure | – | Drug: Statin and SGLT2i30 patients will take statin. |
| Patients has ischemic heart | – | Drug: Statin and SGLT2i30 patients will take both of statin and SGLT2i. |
| Patients has heart disease | – | Drug: Statin and SGLT2i30 patients will take SGLT2i. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Age groups
- Adult, Older 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)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- We exclude patients with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statin and SGLT2iStatin as atrovastatin SGLT2i as dapagliflozin | Drug | Patients has heart disease, Patients has ischemic heart, Patients has ischemic heart failure |
Primary outcome
The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease
Time frame: Three months of follow up
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...)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided. After ending the study, I will share it in magazin with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 2 Drugs Are Statin and SGLT2i, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raghda Roshdy (01010647666, Raghda.hussien@pharm.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of The combination Therapy of Statin and SGLT2i in The Treatment of Ischemic Heart disease (time frame: Three months of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.