Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling
NCT ID: NCT05993897
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-08-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Dapagliflozin
patients who will receive SGLT2 inhibitors
Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
10 mg of Dapagliflozin orally once daily
Rhythm control and anticoagulation
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.
Placebo
Patients who will receive Rhythm control +/- oral anticoagulation
Rhythm control and anticoagulation
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.
Interventions
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Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
10 mg of Dapagliflozin orally once daily
Rhythm control and anticoagulation
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.
Eligibility Criteria
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Inclusion Criteria
2. Patient age 18-60 years.
3. Patients with Glomerular Filtration Rate (GFR) \>45 ml/min/1.73m2 (Cockcroft-Gault equation).
4. Patient with normal left atrium or dilated (diameter \<5 cm)
Exclusion Criteria
2. Patients with valvular heart diseases (Moderate to severe MS, severe AS, Prosthetic heart valves).
3. Patients with left atrium \> 5cm.
4. Patients with glomerular Filtration Rate (GFR) \<45 ml/min/1.73m2 (Cockcroft-Gault equation).
5. Patient with ischemic heart disease (previous MI, UA, PCI or CABG).
6. Patient with previous ischemic stroke.
18 Years
60 Years
ALL
No
Sponsors
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Aswan University
OTHER
Responsible Party
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Aml Soliman
Lecturer of cardiology, Aswan university
Other Identifiers
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693/11/22
Identifier Type: -
Identifier Source: org_study_id
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