SGLT2 Inhibitor for Severe Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

— Reduction-TR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686616
• Other study ID #: Reduction TR
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: March 3, 2025

Study information

• Verified date: January 2023
• Source: Samsung Medical Center
• Contact: Eun Kyoung Kim, MD. PhD
• Phone: 82-2-3410-3419
• Email: ekbobi.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 3, 2025
• Est. primary completion date: April 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Drug:
• Dapagliflozin Propanediol Hydrate 12.3 mg
Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of cardiovascular death or hospitalization for right heart failure* during 12 months	development of cardiovascular death or admission for heart failure	12 months after enrollment
Other	Occurrence of tricuspid valve surgery during 12 months	TV surgery	12 months after enrollment
Other	Difference of NT-proBNP from baseline to 12 months follow-up	NT-proBNP at 12 months - NT-proBNP at baseline	Baseline and month 12
Other	Occurrence of renal dysfunction (creatinine > 2mg/dL)	Newly developed renal dysfunction during follow-up period	12 months after enrollment
Primary	Difference of RVESVi by CMR from baseline to 12 months follow-up (?RVESVi)	RVESV index at 12 months - RVESV index at baseline	Baseline and month 12
Secondary	Difference of RVEDVi by CMR from baseline to 12 months follow-up (?RVEDVi)	RVEDV index at 12 months - RVEDV index at baseline	Baseline and month 12
Secondary	Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (?RVEF)	RVEF at 12 months - RVEF at baseline	Baseline and month 12
Secondary	Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (?VCW)	TR VCW at 12 months - TR VCW at baseline	Baseline and month 12
Secondary	Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up	Tricuspid annulus diameter at 12 months - Tricuspid annulus diameter at baseline	Baseline and month 12
Secondary	Difference of TR volume by CMR from baseline to 12 months follow-up	TR volume at 12 months - TR volume at baseline	Baseline and month 12