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NCT Number: NCT07186153

Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling in Diabetic Patients

To evaluate and follow-up left atrial volume, diastolic function by 2D echocardiography and left atrial strain parameters using speckle-tracking echocardiography in patients with type 2 diabetes mellitus (T2DM) before and after treatment with SGLT2 inhibitors

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Key information

Conditions

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

Diabetes mellitus (DM) is a chronic metabolic disorder that significantly increases cardiovascular morbidity and mortality. Among the earliest manifestations of diabetic heart disease is subclinical cardiac dysfunction, which includes left atrial (LA) remodeling and impaired LA function.

LA remodeling encompasses changes in atrial size, geometry, wall stress, and mechanical function, and serves as an early marker of diastolic dysfunction and elevated left ventricular (LV) filling pressures.

These changes are key contributors to the development of heart failure, particularly heart failure with preserved ejection fraction (HFpEF)[4]and is closely associated with an increased risk of atrial fibrillation (AF).

Conventional echocardiographic parameters often fail to detect early LA dysfunction. Recent advances have highlighted left atrial strain-measured via speckle tracking echocardiography (STE)-as a more sensitive and early marker of LA dysfunction . LA strain assessment, especially during the reservoir, conduit, and contraction phases, provides insights into atrial compliance, stiffness, and overall diastolic function, often preceding structural alterations.

Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors are a class of antihyperglycemic agents that have demonstrated significant cardiovascular benefits in clinical trials. Beyond glycemic control, these agents have been linked to favorable cardiac remodeling, improved diastolic function, and reduced filling pressures. However, their impact on LA function, particularly as assessed by strain parameters, remains underexplored

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed T2DM on antidiabetic medication not including SGLT2 inhibitors.
  • HbA1c ≤ 7%.
  • Age 40-75 years.
  • Sinus rhythm.
  • Informed consent obtained

Exclusion criteria

  • History of atrial fibrillation or flutter.
  • Patients treated with SGLT2 inhibitors.
  • Severe mitral valve regurgitation or stenosis.
  • Previous myocardial infarction.
  • Previous percutaneous coronary intervention(PCI) or coronary artery bypass grafting (CABG).
  • LV Ejection fraction <50% .
  • Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
  • Uncontrolled hypertension (BP > 160/100 mmHg)
  • Inadequate echocardiographic windows or incomplete data

Treatment and study plan

Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor

Drug

evaluate and follow-up left atrial volume, diastolic function by 2D echocardiography and left atrial strain parameters using speckle-tracking echocardiography in patients with type 2 diabetes mellitus (T2DM) after treatment with SGLT2 inhibitors

Other names: Empagliflozin, Dapagliflozin

Primary outcomes

  1. follow-up and evaluation of LA remodeling in patients with type-2 diabetes mellitus ( T2DM) before and after treatment with SGLT2 inhibitors

    Time frame: 6 months follow-up

    The study aims evaluation and follow-up of Left Atrial Strain Parameters assessed by Speckle-Tracking Echocardiography (STE) before and after treatment with SGLT2 inhibitors in patients with type-2 diabetes mellitus at Baseline and 6 months follow-up .

    Left atrial strain will be measured using 2D speckle-tracking echocardiography, including reservoir strain (%), conduit strain (%), and contraction strain (%)

Study contacts

Contact information is provided by the study sponsor or research team.

Abanoub Fayoumy Shawky, Bachelor

CONTACT

[email protected]

+201207937601

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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