Clinical trial NCT05686616: SGLT2 Inhibitor for Severe Tricuspid Regurgitation
Official title: Multicenter, Randomized, Controlled Trial to Assess the Efficacy of Sodium Glucose Cotransporter-2 Inhibitor add-on Treatment in Patients With Severe Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: tricuspid regurgitation
SGLT2 inhibitor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
timeFrame: Baseline and month 12
Secondary outcomes:
measure: Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)
timeFrame: Baseline and month 12
measure: Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)
timeFrame: Baseline and month 12
measure: Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW)
timeFrame: Baseline and month 12
measure: Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up
timeFrame: Baseline and month 12
measure: Difference of TR volume by CMR from baseline to 12 months follow-up
timeFrame: Baseline and month 12
Other outcomes:
measure: Occurrence of cardiovascular death or hospitalization for right heart failure* during 12 months
timeFrame: 12 months after enrollment
measure: Occurrence of tricuspid valve surgery during 12 months
timeFrame: 12 months after enrollment
measure: Difference of NT-proBNP from baseline to 12 months follow-up
timeFrame: Baseline and month 12
measure: Occurrence of renal dysfunction (creatinine > 2mg/dL)
timeFrame: 12 months after enrollment
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Heart Vascular Stroke Institute, Samsung Medical Center
name: Sung Ji Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: