SGLT2 Inhibitor for Severe Tricuspid Regurgitation
- Sponsor
- Samsung Medical Center
- Study ID
- NCT05686616
- Status
- Unknown
Conditions
- Tricuspid Regurgitation
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin Propanediol Hydrate 12.3 mg — DRUGForxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.
Study Details
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.
Key Dates
- Start date
- Apr 13, 2022
- Status verified
- Jan 2023
- Primary completion
- Apr 13, 2024
- Completion
- Mar 3, 2025
Study Design
- Enrollment
- 72 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: SGLT2 inhibitor groupParticipants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks.
- No Intervention: Conventional treatment groupParticipants will continue the existing medications for severe TR.
Primary Outcome Measure
Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi) [ Time Frame: Baseline and month 12 ]
Central Contacts
- Eun Kyoung Kim, MD. PhD82-2-3410-3419
- Ji Hoon Kim, MD, PhD82-2-3410-3419
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