SGLT2 Inhibitor for Severe Tricuspid Regurgitation (Reduction-TR)

Samsung Medical Center

Status: Enrolling

Conditions: Tricuspid Regurgitation

Treatments: Drug: Dapagliflozin Propanediol Hydrate 12.3 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05686616

Reduction TR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant over 20 years of age who understands the research protocol and has written informed consent

2. Participant with severe tricuspid valve regurgitation

   • Vena contracta width > 0.7cm or effective regurgitant orifice (ERO)≥40mm2 for more than 1 month despite medical treatment
   • Participant with left ventricular ejection fraction ≥ 40%
   • Participant with NYHA class II or more

Exclusion criteria

1. Patient with severe mitral valve or aortic valve disease
2. Left ventricular ejection fraction less than 40%*
3. Patient with severe pulmonary hypertension (TR Vmax > 4m/s)
4. Patient with acute heart failure or dyspnea of NYHA functional class IV or higher
5. Symptomatic hypotension or systolic blood pressure < 90 mmHg at screening
6. Patient with severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary embolism)
7. Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis
8. Patient with Type 1 diabetes
9. If a woman of childbearing potential has not used double contraception
10. Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging
11. Blood AST or ALT value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites)
12. Life expectancy is less than one year
13. Patient who already take SGLT-2 inhibitor
14. A history of hypersensitivity or allergy to SGLT2 inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

SGLT2 inhibitor group

Active Comparator group

Description:

Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks.

Treatment:

Drug: Dapagliflozin Propanediol Hydrate 12.3 mg

Conventional treatment group

No Intervention group

Description:

Participants will continue the existing medications for severe TR.