NCT05686616

SGLT2 Inhibitor for Severe Tricuspid Regurgitation

Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.

Detailed description

After being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to SGLT2i add-on group or conventional treatment group.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DRUG	Dapagliflozin Propanediol Hydrate 12.3 mg	Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.

Timeline

• Start date: 2022-04-13
• Primary completion: 2024-04-13
• Completion: 2025-03-03
• First posted: 2023-01-17
• Last updated: 2023-01-17

Locations

1 site across 1 country: South Korea