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Not yet recruiting NCT07186153

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

— Observational SGLT 2 Inhibitors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor.
Who it may be relevant to
Registry conditions: SGLT 2 Inhibitors. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Detailed description

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

Interventions

  • Drug Sodium Glucose Co-transporter 2 (SGLT2) Inhibitor
    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

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Rehman SU, Rahman F. Evidence-Based Clinical Review on Cardiovascular Benefits of SGLT2 (Sodium-Glucose Co-Transporter Type 2) Inhibitors in Type 2 Diabetes Mellitus. Cureus. 2020 Aug 11;12(8):e9655. doi: 10.7759/cureus.9655. PMID 32802621
  • Yuda S. Current clinical applications of speckle tracking echocardiography for assessment of left atrial function. J Echocardiogr. 2021 Sep;19(3):129-140. doi: 10.1007/s12574-021-00519-8. Epub 2021 Mar 9. PMID 33687616
  • Swoboda PP, McDiarmid AK, Erhayiem B, Ripley DP, Dobson LE, Garg P, Musa TA, Witte KK, Kearney MT, Barth JH, Ajjan R, Greenwood JP, Plein S. Diabetes Mellitus, Microalbuminuria, and Subclinical Cardiac Disease: Identification and Monitoring of Individuals at Risk of Heart Failure. J Am Heart Assoc. 2017 Jul 17;6(7):e005539. doi: 10.1161/JAHA.117.005539. PMID 28716801
  • Nattel S, Burstein B, Dobrev D. Atrial remodeling and atrial fibrillation: mechanisms and implications. Circ Arrhythm Electrophysiol. 2008 Apr;1(1):62-73. doi: 10.1161/CIRCEP.107.754564. No abstract available. PMID 19808395
  • Tadic M, Cuspidi C. Left atrial function in diabetes: does it help? Acta Diabetol. 2021 Feb;58(2):131-137. doi: 10.1007/s00592-020-01557-x. Epub 2020 Jun 9. PMID 32519220
  • Fan W. Epidemiology in diabetes mellitus and cardiovascular disease. Cardiovasc Endocrinol. 2017 Feb 15;6(1):8-16. doi: 10.1097/XCE.0000000000000116. eCollection 2017 Mar. PMID 31646113

Identifiers

NCT: NCT07186153 · Effect of SGLT2 on LAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗