A Phase 3 interventional study of Carvedilol+Empagliflozin and Carvedilol in Tricuspid Regurgitation and Right Ventricular Dilatation, sponsored by Asan Medical Center. Completed at 3 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by Asan Medical Center · Phase 3, Interventional, and Treatment
Functional tricuspid regurgitation (TR) has been regarded as a secondary phenomenon of heart failure (HF), mitral valve (MV) disease or atrial fibrillation. Regardless of left ventricular (LV) function or pulmonary artery pressure, presence of moderate or greater functional TR is associated with poor prognosis. When a patient develops functional TR, it causes RV dilation and tricuspid annular enlargement, which also lead to deterioration of TR. A vicious cycle of significant TR, RV volume overload, tricuspid annular dilation and consequent aggravation of TR is accepted as a main determinant of the poor clinical outcome of patients with TR. Therefore, therapies that induce reverse remodeling of the RV and consequently reduce TR, may improve clinical outcomes. However, there have been no proven medical therapies for TR. The investigators hypothesize that carvedilol or empagliflozin is effective on improving RV remodeling in patients with functional severe TR and try to examine this hypothesis in a multicenter, 2x2 factorial, and randomized comparison study using cardiac MRI.
Functional tricuspid regurgitation (TR) has been regarded as a secondary phenomenon of heart failure (HF), mitral valve (MV) disease or atrial fibrillation. The prevalence of functional TR was reported to be 25-64% in patients with either ischemic or non-ischemic cardiomyopathy. Regardless of left ventricular (LV) function or pulmonary artery pressure, presence of moderate or greater functional TR is associated with poor prognosis. When a patient develops functional TR, it causes RV dilation and tricuspid annular enlargement, which also lead to deterioration of TR. A vicious cycle of significant TR, RV volume overload, tricuspid annular dilation and consequent aggravation of TR is accepted as a main determinant of the poor clinical outcome of patients with TR. Because the quantitative assessment of RV size and function using echocardiography is often limited due to the complex geometry of RV, cardiac magnetic resonance imaging (MRI) has emerged as a gold standard for evaluating RV volume and function with excellent accuracy and reproducibility. The investigators previously reported that RV end-systolic volume index (ESVI) and RV end-diastolic volume index (EDVI) measured by MRI were significantly larger in severe TR patients, and also found that preoperative RV ESVI and RV ejection fraction (EF) on MRI were independent predictors of cardiac death and postoperative adverse events in patients who underwent TV surgery for severe functional TR. Therefore, therapies that induce reverse remodeling of the RV and consequently reduce TR, may improve clinical outcomes. However, there have been no proven medical therapies for TR. The morbidity and mortality of patients with functional TR remain high and novel therapeutic agents are needed to improve the prognosis of patients with functional TR. The investigators hypothesize that carvedilol or empagliflozin is effective on improving RV remodeling in patients with functional severe TR and try to examine this hypothesis in a multicenter, 2x2 factorial, and randomized comparison study using cardiac MRI.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 118 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
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Patients with severe functional tricuspid regurgitation
Exclusion Criteria:
Contraindication for MRI
Patients will receive carvedilol SR 16mg and empagliflozin 10mg qd.
Drug: Carvedilol+Empagliflozin
Patients will receive carvedilol SR 16mg alone.
Drug: Carvedilol
Patients will receive empagliflozin 10mg and matching placebo of carvedilol.
Drug: Empagliflozin
Patients will receive matching placebo of carvedilol.
Drug: Placebo
Group A
Also known as: Dilatrend SR+Jardiance
Group B
Also known as: Dilatrend SR
Group C
Also known as: Jardiance
Group D
Also known as: Matching placebo of Dilatrend SR
Change of RV end-systolic volume index
Change of RV end-systolic volume index by cardiac MRI
Time frame: from baseline to 12 months follow-up
Change of RV end-diastolic volume index
Change of RV end-diastolic volume index by cardiac MRI
Time frame: from baseline to 12 months follow-up
Change of RV ejection fraction
Change of RV ejection fraction by cardiac MRI
Time frame: from baseline to 12 months follow-up
Change of vena contract width of TR
Change of vena contract width of TR by echocardiography
Time frame: from baseline to 12 months follow-up
Occurrences of death from cardiovascular causes or hospitalization for heart failure
Clinical outcome
Time frame: the entire follow-up period (continuing until 12 months after the last patient was enrolled)
Occurrences of death from any causes
Clinical outcome
Time frame: the entire follow-up period (continuing until 12 months after the last patient was enrolled)
Plan to share: Undecided
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