Heart FailureNCT06585761
Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
An observational study of Heart Failure, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- SGLT2 inhibitor and echo cardiogram
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: participants who are candidates for SGLT2i and will be recruited from Cardiology Department, Kafrelshiekh University Hospital.
Who may be able to join
- Patients aged more than 18 years old.
- Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)
- Patients are on standard therapy for management of HF (according to AHA/ACC/HFSA Guideline for the Management of Heart Failure2022)21 such as:
- ACEi (angiotensin converting enzyme inhibitor)
- ARB (angiotensin receptor blocker)
- ARNI in place of ACEi OR ARB
Show all 10Show fewer
- Beta blocker
- (MRA) Mineralocorticoid receptor antagonists
- Diuretics as needed.
- All patients signed the informed consent.
Who cannot join
- Patients suffering from conditions like acute CVS illness and severe sepsis that raise inflammatory markers and may lead to cardiac dysfunction as opposed to heart failure.
- Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.
- Female patients during pregnancy or lactation
- Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR <20 mL/min/1.73 m²).
- Individuals suffering from verbal communication disorders or psychic cognitive impairment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University Hospital
Kafr ash Shaykh, 33516
Nada Nabil Mohammed Elsalhey, Bsc, 01062787805, nada.nabil@pharm.kfs.edu.eg
About this study
The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.
- Conditions
- Heart Failure
- Being tested
- SGLT2 inhibitor, echo cardiogram
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called empagliflozin, Dapagliflozin
patients with HF are subjected to regular dose of SGLT2I member according to patient status.
echo cardiogramDevice
the patients are subjected to ECHO to determine their EF prior to and post the study
| Study group | Role | What they receive |
|---|---|---|
| pre-SGLT2I group | patients with heart failure newly introduced to one of SGLT2I members Receives: Device: echo cardiogram | |
| Post-SGLT2I group | patients with heart failure on one of SGLT2I members for at least 2 months Receives: Drug: SGLT2 inhibitor; Device: echo cardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention
At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL.
Measured: 1 year
clinical examination for the presence and extent of improvement in signs and symptoms
Clinical examination depending on NYHA classification of the participants
Measured: 1 year
Secondary outcomes (2)
measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention
At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarker
Il-6 serum concentration is measured in pg/mL
Measured: 1 year
Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention
TNF-Alpha serum concentration is measured in pg/ml
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start15 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Nabil Elsalhey, Kafrelsheikh University
- Investigators
- Nada Nabil Mohammed Elsalhey, Bsc, Principal investigator, clinical pharmacy department, kafrelsheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585761
- Sponsor's protocol ID
- KFSIRB200-128
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: not yet decided by participant
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06585761
- Acronym / sponsor ID
- KFSIRB200-128
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Sep 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.
The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-SGLT2I group | – | Device: echo cardiogrampatients with heart failure newly introduced to one of SGLT2I members |
| Post-SGLT2I group | – | Drug: SGLT2 inhibitor, Device: echo cardiogrampatients with heart failure on one of SGLT2I members for at least 2 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants who are candidates for SGLT2i and will be recruited from Cardiology Department, Kafrelshiekh University Hospital.
Key inclusion criteria (10 listed)
- Patients aged more than 18 years old.
- Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)
- Patients are on standard therapy for management of HF (according to AHA/ACC/HFSA Guideline for the Management of Heart Failure2022)21 such as:
- All patients signed the informed consent.
Key exclusion criteria (5 listed)
- Patients suffering from conditions like acute CVS illness and severe sepsis that raise inflammatory markers and may lead to cardiac dysfunction as opposed to heart failure.
- Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.
- Female patients during pregnancy or lactation
- Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR <20 mL/min/1.73 m²).
- Individuals suffering from verbal communication disorders or psychic cognitive impairment.
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 |
|---|---|---|
| SGLT2 inhibitorAlso: empagliflozin, Dapagliflozinpatients with HF are subjected to regular dose of SGLT2I member according to patient status. | Drug | Post-SGLT2I group |
| echo cardiogramthe patients are subjected to ECHO to determine their EF prior to and post the study | Device | Post-SGLT2I group, pre-SGLT2I group |
Primary outcome
measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention
Time frame: 1 year
At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL.
clinical examination for the presence and extent of improvement in signs and symptoms
Time frame: 1 year
Clinical examination depending on NYHA classification of the participants
2 secondary outcomes
measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention
Time frame: 1 year
Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided. not yet decided by participant
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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. This study is not recruiting at the moment.
Nada Nabil Mohammed Elsalhey, Bsc principal investigator
clinical pharmacy department, kafrelsheikh university
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 Heart Failure, run by Kafrelsheikh 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 10 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada Nabil mohammed elsalhey, BSC (+201062787805, nada.nabil@pharm.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention (time frame: 1 year). The study lists 2 primary outcomes in all. 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 5 Sep 2024.