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The effect of SGLT2 inhibitors on left atrial Function in patients with Hypertension: A prospective, Randomized, open-access, blinded endpoint assessment study (PROBE-RCT)

The effect of SGLT2 inhibitors on left atrial Function in patients with Hypertension: A prospective, Randomized, open-access, blinded endpoint assessment study (PROBE-RCT)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116590
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Interventional group:In addition to standard antihypertensive therapy (SoC), one tablet of SGLT2 inhibitor (dapagliflozin 10 mg or empagliflozin 10 mg) was administered daily. Other antihypertensive m
any adjustments according to guidelines required detailed documentation.
Control group:Continue current standard antihypertensive therapy (SoC) without the use of SGLT2 inhibitors.

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 30 to 80, diagnosed with essential hypertension. 2. Left ventricular ejection fraction (LVEF) >=50%. 3.Evidence of abnormal LA function/load (meeting any of the following conditions) : (1) LASr 0.6 (3) LAVI > 34 mL/m^2. 4.Currently receiving standard antihypertensive treatment with a stable regimen for at least 4 weeks. 5.Voluntarily sign the informed consent form and be able to cooperate in completing all research visits and examinations.

Exclusion criteria

Exclusion criteria: 1. The estimated glomerular filtration rate (eGFR) is less than 45 mL/min/1.73 m^2 or there are contraindications for the use of SGLT2i. 2. There is a history of recurrent urinary and reproductive system infections or diabetic ketoacidosis. 3. Accompanied by significant valvular heart disease, recent acute coronary syndrome, myocarditis or a history of cardiac surgery. 4. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Left atrial reservoir strain;

Secondary

MeasureTime frame
Left atrial functional reserve;Left Atrial Volume Index;Left Atrial Stiffness Index;Left Ventricular Global Longitudinal Strain;Diastolic Function Parameters ;Tricuspid Regurgitation Velocity;

Countries

China

Contacts

Public ContactFu Huaying

The Second Hospital of Tianjin Medical University

huayingfu@126.com+86 138 2040 6212

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026