Less regurgitation without reverse remodeling: what the PROVE trial teaches us about functional tricuspid regurgitation

Q: What is the clinical evidence from this study?

Study design: Editorial. Population: Significant functional tricuspid regurgitation (n=56). Intervention: Empagliflozin and sustained-release carvedilol vs. Matching placebo for carvedilol; guideline-directed therapy alone for empagliflozin. Primary outcome: Change in right ventricular (RV) end-systolic volume index measured by cardiac magnetic resonance (CMR).

Hyun‐Jin Kim

doi:10.1186/s44348-026-00100-w

October 8, 2026Journal of Cardiovascular ImagingOpen Access

Less regurgitation without reverse remodeling: what the PROVE trial teaches us about functional tricuspid regurgitation

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Why the study?

Does empagliflozin and/or carvedilol improve right ventricular volume or tricuspid regurgitation severity in patients with significant functional tricuspid regurgitation?

Key Points

To determine the impact of carvedilol and empagliflozin on right ventricular reverse remodeling and regurgitation severity in functional tricuspid regurgitation.
Study using a two-by-two factorial design testing sustained-release carvedilol 16 mg daily, empagliflozin 10 mg daily, both agents, or placebo for 12 months.
Enrolled 56 patients (44 analyzed; halted early from 180 planned due to the COVID-19 pandemic) with significant functional tricuspid regurgitation and left ventricular ejection fraction of at least 50%.
The primary endpoint, change in right ventricular end-systolic volume index measured by cardiac magnetic resonance, did not differ among the groups.
Empagliflozin reduced vena contracta width by 1.45 mm (95% CI, 0.69–2.20), effective regurgitant orifice area by 0.09 cm 2 (95% CI, 0.02–0.17), and regurgitant volume by 10.7 mL (95% CI, 4.2–17.2) compared to placebo.

Structured PICO

Does empagliflozin and/or carvedilol improve right ventricular volume or tricuspid regurgitation severity in patients with significant functional tricuspid regurgitation?

P

Population

56 patients with significant functional tricuspid regurgitation and LVEF ≥50% (mean age 71) followed for 12 months.

I

Intervention

Empagliflozin 10 mg daily and/or sustained-release carvedilol 16 mg daily in a 2x2 factorial design for 12 months.

C

Comparator

Matching placebo for carvedilol; guideline-directed therapy alone for empagliflozin.

O

Outcome

Change in right ventricular (RV) end-systolic volume index measured by cardiac magnetic resonance (CMR).surrogate

Limitations

Enrollment was halted early at 56 of 180 planned patients due to the COVID-19 pandemic, rendering the trial underpowered
Did not report right atrial volume, annular dimensions, or coaptation gap
CMR and echocardiography assessments were separated by a median of 28 days
Asymmetric blinding at the patient and investigator level
Underpowered due to early termination from the COVID-19 pandemic (56 of 180 planned patients enrolled)
Absolute reduction in RV volume it was designed to detect was unlikely to be delivered by this phenotype
Asymmetric blinding

Implication

In patients with atrial functional tricuspid regurgitation, medical therapy such as empagliflozin may improve valve regurgitation severity without necessarily reversing right ventricular remodeling.

Abstract

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Discussion

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Cite This Study

Hyun‐Jin Kim (2026) conducted an editorial in Significant functional tricuspid regurgitation (n=56). Empagliflozin and sustained-release carvedilol vs. Matching placebo for carvedilol; guideline-directed therapy alone for empagliflozin was evaluated on Change in right ventricular (RV) end-systolic volume index measured by cardiac magnetic resonance (CMR).

synapsesocial.com/papers/6acb02609532816172c861dd https://doi.org/10.1186/s44348-026-00100-w

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Less regurgitation without reverse remodeling: what the PROVE trial teaches us about functional tricuspid regurgitation

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

Less regurgitation without reverse remodeling: what the PROVE trial teaches us about functional tricuspid regurgitation

Key Points

Structured PICO

Limitations

Implication

Abstract

Discussion

Cite This Study

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