Atrial FibrillationNCT05993897
Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling
A study testing Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor in people with Atrial Fibrillation, run by Aswan University at 1 site in Egypt.
Trial summary
Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes status. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2024to 15 Oct 2025
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or with intervention within seven days of onset).
- Patient age 18-60 years.
- Patients with Glomerular Filtration Rate (GFR) >45 ml/min/1.73m2 (Cockcroft-Gault equation).
- Patient with normal left atrium or dilated (diameter <5 cm)
Who cannot join
- Patients < 18 yrs old.
- Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
- Patients with left atrium > 5cm.
- Patients with glomerular Filtration Rate (GFR) <45 ml/min/1.73m2 (Cockcroft-Gault equation).
- Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
- Patient with previous ischemic stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes status.
- Conditions
- Atrial Fibrillation
- Being tested
- Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor, Rhythm control and anticoagulation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Glucose Co-transporter 2 (SGLT2) InhibitorDrug
10 mg of Dapagliflozin orally once daily
Rhythm control and anticoagulationDrug
In acute stage: Cardioversion with D.C shock if haemodynamically unstable, after failure of pharmacological cardioversion or participant preference.
or pharmacological cardioversion with either IV cordarone in structurally abnormal heart (150mg over 10 minutes followed by1 mg/min infusion for 6 hours followed by 0.5 mg/min not exceeding 2.4 grams over 24 hours till restoration of sinus Rhythm. Then maintenance dose of 200 mg tab orally every 8 hours for 3 weeks then 200 mg tab orally once per day.
or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours.
+ Rivaroxaban 20mg orally once daily if CHA2DS2 VASc score 1 or more for males and 2 or more for females.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Active comparator | patients who will receive SGLT2 inhibitors Receives: Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor; Drug: Rhythm control and anticoagulation |
| Placebo | Placebo comparator | Patients who will receive Rhythm control +/- oral anticoagulation Receives: Drug: Rhythm control and anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left atrial remodeling
by measuring Indexed LA volume (LAVI) in ml/m2
Measured: Before first administration of treatment and will be repeated 6 months after while still on treatment
Changes in left atrial strain
by measuring left atrial strain %
Measured: Before first administration of treatment and will be repeated 6 months after while still on treatment
Changes in left atrial systolic force
by measuring left atrial systolic force in ml/m3
Measured: Before first administration of treatment and will be repeated 6 months after while still on treatment
Secondary outcomes (4)
Mean percentage of time spent in atrial fibrillation
By documented ECG or Holter monitoring
Measured: After the first dose of treatment till the end of the study (1 year)
Mortality Rate
all cause mortality
Measured: After the first dose of treatment till the end of the study (1 year)
Incidence of Hospitalization due to HF
In hospital admission by HF symptoms
Measured: After the first dose of treatment till the end of the study (1 year)
Number of participants with Stroke
Ischemic or hemorrhagic
Measured: After the first dose of treatment till the end of the study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start20 Aug 2024
- Primary completion30 Jun 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Soliman, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993897
- Sponsor's protocol ID
- 693/11/22
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrium Remodeling in Non-valvular Paroxysmal Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT05993897
- Acronym / sponsor ID
- 693/11/22
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 15 Aug 2023 (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.
Investigators are going to assess direct effect of SGLT2 inhibitors on left atrial remodeling in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Active comparator | Drug: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor, Drug: Rhythm control and anticoagulationpatients who will receive SGLT2 inhibitors |
| Placebo | Placebo comparator | Drug: Rhythm control and anticoagulationPatients who will receive Rhythm control +/- oral anticoagulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- with non-valvular paroxysmal atrial fibrillation (AF that terminates spontaneously or with intervention within seven days of onset).
- Patient age 18-60 years.
- Patients with Glomerular Filtration Rate (GFR) >45 ml/min/1.73m2 (Cockcroft-Gault equation).
- Patient with normal left atrium or dilated (diameter <5 cm)
Key exclusion criteria (6 listed)
- Patients < 18 yrs old.
- Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
- Patients with left atrium > 5cm.
- Patients with glomerular Filtration Rate (GFR) <45 ml/min/1.73m2 (Cockcroft-Gault equation).
- Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
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 |
|---|---|---|
| Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor10 mg of Dapagliflozin orally once daily | Drug | Dapagliflozin |
| Rhythm control and anticoagulationIn acute stage: Cardioversion with D.C shock if haemodynamically unstable, after failure of pharmacological cardioversion or participant preference. or pharmacological cardioversion with either IV cordarone in structurally abnormal heart (150mg over 10 minutes followed by1 mg/min infusion for 6 hours followed by 0.5 mg/min not exceeding 2.4 grams over 24 hours till restoration of sinus Rhythm. Then maintenance dose of 200 mg tab orally every 8 hours for 3 weeks then 200 mg tab orally once per day. or Propafenone (Rytmonorm) 600 mg single oral dose in structurally normal heart then maintenance dose of 150mg tab orally every 8 hours. + Rivaroxaban 20mg orally once daily if CHA2DS2 VASc score 1 or more for males and 2 or more for females. | Drug | Dapagliflozin, Placebo |
Primary outcome
Left atrial remodeling
Time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring Indexed LA volume (LAVI) in ml/m2
Changes in left atrial strain
Time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring left atrial strain %
Changes in left atrial systolic force
Time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment
by measuring left atrial systolic force in ml/m3
4 secondary outcomes
Mean percentage of time spent in atrial fibrillation
Time frame: After the first dose of treatment till the end of the study (1 year)
Mortality Rate
Time frame: After the first dose of treatment till the end of the study (1 year)
Incidence of Hospitalization due to HF
Time frame: After the first dose of treatment till the end of the study (1 year)
Number of participants with Stroke
Time frame: After the first dose of treatment till the end of the study (1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor in people with Atrial Fibrillation, run by Aswan 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left atrial remodeling (time frame: Before first administration of treatment and will be repeated 6 months after while still on treatment). The study lists 3 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 13 Jul 2026.