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September 15, 2026Journal of Cardiovascular ImagingOpen Access

Empagliflozin fails to reduce RV end-systolic volume index versus placebo but lessens tricuspid regurgitation severity.

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Why the study?

Functional TR and RV remodeling form a vicious cycle linked to adverse outcomes, creating a need for therapies that reverse RV remodeling and reduce TR.

Does empagliflozin, sustained-release carvedilol, or their combination improve right ventricular remodeling and reduce tricuspid regurgitation severity in patients with significant functional tricuspid regurgitation?

Population

56 patients with significant functional TR

Comparison

Carvedilol SR plus empagliflozin vs carvedilol SR vs empagliflozin vs placebo

Design

Randomized trial with a 2 × 2 factorial design

Follow-up

12 months

Key result

Empagliflozin did not significantly reduce right ventricular end-systolic volume index compared with placebo (MD 1.67 mL/m2, p=0.708), although it significantly reduced secondary measures of tricuspid regurgitation severity.

Authors

GKGa Yun KimSLSomin LimDYDong Hyun Yang

Discussion

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Overview

Empagliflozin should not target right ventricular remodeling in functional tricuspid regurgitation; extends evidence for possible regurgitation reduction pending larger trials.

Key Points

  • To determine whether sustained-release carvedilol, empagliflozin, or their combination reduces right ventricular volumes and tricuspid regurgitation severity in patients with significant functional tricuspid regurgitation.
  • A randomized 2 × 2 factorial trial (N=56; NCT04345796) assigned patients to sustained-release carvedilol plus empagliflozin, sustained-release carvedilol, empagliflozin, or placebo for 12 months.
  • The primary endpoint was change in right ventricular end-systolic volume index assessed by cardiac magnetic resonance imaging at 12 months, with tricuspid regurgitation severity evaluated by echocardiography.
  • Empagliflozin did not significantly change right ventricular volumes or right ventricular ejection fraction compared with placebo over 12 months.
  • Empagliflozin significantly decreased tricuspid regurgitation severity versus placebo, reducing vena contracta width (1.45 mm; 95% CI, 0.69–2.20), effective regurgitant orifice area (0.09 cm²; 95% CI, 0.02–0.17), and regurgitant volume (10.7 mL; 95% CI, 4.2–17.2).
  • Sustained-release carvedilol showed no significant effect on primary or secondary endpoints, while carvedilol plus empagliflozin reduced vena contracta width (−0.78 ± 1.15 mm vs. 0.56 ± 1.45 mm, P = 0.03) without altering other parameters.

Study Design

Type

RCT (n=56)

Blinding

Assessor-blinded

Randomization

Computerized randomization system with 2x2 factorial design

Multicenter

Yes

Structured PICO

Does empagliflozin, sustained-release carvedilol, or their combination improve right ventricular remodeling and reduce tricuspid regurgitation severity in patients with significant functional tricuspid regurgitation?

P
Population
56 adults with stable heart failure, LVEF ≥ 50%, and significant functional tricuspid regurgitation were randomized to carvedilol SR, empagliflozin, their combination, or placebo and followed for 12 months.
I
Intervention
Empagliflozin, sustained-release carvedilol, or their combination for 12 months
C
Comparator
Placebo
O
Outcome
Change in right ventricular (RV) end-systolic volume index from baseline to 12 monthssurrogate

Main Result

Mean Difference: 1.67 (95% CI -7.25–10.59)

Absolute Event Rate: -1.97% vs -3.64%

p-value: p=0.708

In patients with functional tricuspid regurgitation, empagliflozin significantly reduces tricuspid regurgitation severity but does not improve right ventricular remodeling.

Limitations

  • Underpowered study due to the COVID-19 pandemic affecting enrollment, failing to reach the calculated sample size.
  • Primary analysis did not follow the intention-to-treat principle and included only patients who completed the study.
  • Matching placebo for empagliflozin was not provided (though assessors were blinded).
  • The daily dose of carvedilol SR used was lower than the target dose recommended for heart failure with reduced ejection fraction.
  • Results may not be applicable to patients with LVEF < 50%.
  • Small mechanistic study without formal adjustment for multiple comparisons.

Cite This Study

Kim et al. (2026) conducted an RCT in Functional tricuspid regurgitation and stable heart failure (n=56). Empagliflozin vs. Placebo was evaluated on Change in right ventricular end-systolic volume index from baseline to 12 months (MD 1.67, 95% CI -7.25 to 10.59, p=0.708). Empagliflozin did not significantly reduce right ventricular end-systolic volume index compared with placebo (MD 1.67 mL/m2, p=0.708), although it significantly reduced secondary measures of tricuspid regurgitation severity.

synapsesocial.com/papers/6aa90187eed42882c1fc1991https://doi.org/10.1186/s44348-026-00095-4
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