NCT05686616

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

January 9, 2023

Last Update Submit

January 9, 2023

Conditions

Tricuspid Regurgitation

Keywords

tricuspid regurgitationSGLT2 inhibitor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Difference of RVEDVi by CMR from baseline to 12 months follow-up (∆RVEDVi)

    Baseline and month 12

  • Difference of RV ejection fraction by CMR from baseline to 12 months follow-up (∆RVEF)

    Baseline and month 12

  • Difference of Vena contracta width of TR by echocardiography from baseline to 12 months follow-up (∆VCW)

    Baseline and month 12

  • Difference of TV annulus diameter by echocardiography from baseline to 12 months follow-up

    Baseline and month 12

  • Difference of TR volume by CMR from baseline to 12 months follow-up

    Baseline and month 12

Other Outcomes (4)

  • Occurrence of cardiovascular death or hospitalization for right heart failure* during 12 months

    12 months after enrollment

  • Occurrence of tricuspid valve surgery during 12 months

    12 months after enrollment

  • Difference of NT-proBNP from baseline to 12 months follow-up

    Baseline and month 12

  • +1 more other outcomes

Study Arms (2)

SGLT2 inhibitor group

ACTIVE COMPARATOR

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

Drug: Dapagliflozin Propanediol Hydrate 12.3 mg

Conventional treatment group

NO INTERVENTION

Participants will continue the existing medications for severe TR.

Interventions

Dapagliflozin Propanediol Hydrate 12.3 mgDRUG

Forxiga 10mg will be added on the conventional treatment for SGL2 inhibitor group.

Also known as: Forxiga Tablet 10mg
SGLT2 inhibitor group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Sung Ji Park, MD, PhD

    Heart Vascular Stroke Institute, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Kyoung Kim, MD. PhD

CONTACT

82-2-3410-3419ekbobi.kim@samsung.com

Ji Hoon Kim, MD, PhD

CONTACT

82-2-3410-3419jh9933.kim@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 17, 2023

Study Start

April 13, 2022

Primary Completion

April 13, 2024

Study Completion

March 3, 2025

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

KR(1)