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SGLT2 Inhibitor for Severe Tricuspid Regurgitation (Reduction-TR)

Primary Purpose

Tricuspid Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin Propanediol Hydrate 12.3 mg
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring tricuspid regurgitation, SGLT2 inhibitor

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant over 20 years of age who understands the research protocol and has written informed consent 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: Patient with severe mitral valve or aortic valve disease Left ventricular ejection fraction less than 40%* Patient with severe pulmonary hypertension (TR Vmax > 4m/s) Patient with acute heart failure or dyspnea of NYHA functional class IV or higher Symptomatic hypotension or systolic blood pressure < 90 mmHg at screening Patient with severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary embolism) Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis Patient with Type 1 diabetes If a woman of childbearing potential has not used double contraception Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging 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) Life expectancy is less than one year Patient who already take SGLT-2 inhibitor A history of hypersensitivity or allergy to SGLT2 inhibitor

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

SGLT2 inhibitor group

Conventional treatment group

Arm Description

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

Participants will continue the existing medications for severe TR.

Outcomes

Primary Outcome Measures

Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
RVESV index at 12 months - RVESV index at baseline

Secondary Outcome Measures

Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)
RVEDV index at 12 months - RVEDV index at baseline
Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)
RVEF at 12 months - RVEF at baseline
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
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
Difference of TR volume by CMR from baseline to 12 months follow-up
TR volume at 12 months - TR volume at baseline

Full Information

First Posted
January 9, 2023
Last Updated
January 9, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05686616
Brief Title
SGLT2 Inhibitor for Severe Tricuspid Regurgitation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
April 13, 2024 (Anticipated)
Study Completion Date
March 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
Keywords
tricuspid regurgitation, SGLT2 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SGLT2 inhibitor group
Arm Type
Active Comparator
Arm Description
Participants will take dapagliflozin propanediol hydrate 12.3 mg once a day for a total of 48 weeks.
Arm Title
Conventional treatment group
Arm Type
No Intervention
Arm Description
Participants will continue the existing medications for severe TR.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin Propanediol Hydrate 12.3 mg
Other Intervention Name(s)
Forxiga Tablet 10mg
Intervention Description
Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.
Primary Outcome Measure Information:
Title
Difference of RVESVi by CMR from baseline to 12 months follow-up (∆RVESVi)
Description
RVESV index at 12 months - RVESV index at baseline
Time Frame
Baseline and month 12
Secondary Outcome Measure Information:
Title
Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)
Description
RVEDV index at 12 months - RVEDV index at baseline
Time Frame
Baseline and month 12
Title
Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)
Description
RVEF at 12 months - RVEF at baseline
Time Frame
Baseline and month 12
Title
Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW)
Description
TR VCW at 12 months - TR VCW at baseline
Time Frame
Baseline and month 12
Title
Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up
Description
Tricuspid annulus diameter at 12 months - Tricuspid annulus diameter at baseline
Time Frame
Baseline and month 12
Title
Difference of TR volume by CMR from baseline to 12 months follow-up
Description
TR volume at 12 months - TR volume at baseline
Time Frame
Baseline and month 12
Other Pre-specified Outcome Measures:
Title
Occurrence of cardiovascular death or hospitalization for right heart failure* during 12 months
Description
development of cardiovascular death or admission for heart failure
Time Frame
12 months after enrollment
Title
Occurrence of tricuspid valve surgery during 12 months
Description
TV surgery
Time Frame
12 months after enrollment
Title
Difference of NT-proBNP from baseline to 12 months follow-up
Description
NT-proBNP at 12 months - NT-proBNP at baseline
Time Frame
Baseline and month 12
Title
Occurrence of renal dysfunction (creatinine > 2mg/dL)
Description
Newly developed renal dysfunction during follow-up period
Time Frame
12 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant over 20 years of age who understands the research protocol and has written informed consent 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: Patient with severe mitral valve or aortic valve disease Left ventricular ejection fraction less than 40%* Patient with severe pulmonary hypertension (TR Vmax > 4m/s) Patient with acute heart failure or dyspnea of NYHA functional class IV or higher Symptomatic hypotension or systolic blood pressure < 90 mmHg at screening Patient with severe lung disease (asthma, obstructive pulmonary disease, acute pulmonary embolism) Patients with renal failure (Estimated GFR < 30 mL/min/1.73 m2) or on dialysis Patient with Type 1 diabetes If a woman of childbearing potential has not used double contraception Patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging 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) Life expectancy is less than one year Patient who already take SGLT-2 inhibitor A history of hypersensitivity or allergy to SGLT2 inhibitor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Kyoung Kim, MD. PhD
Phone
82-2-3410-3419
Email
ekbobi.kim@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Hoon Kim, MD, PhD
Phone
82-2-3410-3419
Email
jh9933.kim@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Ji Park, MD, PhD
Organizational Affiliation
Heart Vascular Stroke Institute, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Kyoung Kim, MD PhD
Phone
82234103419
Email
ekbobi.kim@samsung.com
First Name & Middle Initial & Last Name & Degree
Ji Hoon Kim, MD
Phone
82234103419
Email
jh9933.kim@samsung.com

12. IPD Sharing Statement

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SGLT2 Inhibitor for Severe Tricuspid Regurgitation

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