Tricuspid Regurgitation Clinical Trial
Official title:
Multicenter, Randomized, 2 x 2 Factorial, Phase 3 Study to Assess the Efficacy of Carvedilol and Empagliflozin on Improvement of Right Ventricular Remodeling in Patients With Severe Functional Tricuspid Regurgitation
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05434507 -
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
|
N/A | |
Completed |
NCT03144024 -
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
|
N/A | |
Enrolling by invitation |
NCT05825898 -
Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
|
||
Completed |
NCT05836493 -
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
|
||
Enrolling by invitation |
NCT06033274 -
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
|
||
Recruiting |
NCT05671640 -
Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation
|
N/A | |
Recruiting |
NCT06027307 -
Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation
|
Phase 3 | |
Terminated |
NCT04665583 -
Prehab Prior to Undergoing Tricuspid Intervention
|
||
Recruiting |
NCT06307262 -
European Registry of Transcatheter Repair for Tricuspid Regurgitation
|
||
Completed |
NCT02981953 -
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
|
N/A | |
Recruiting |
NCT04433065 -
TTVR Early Feasibility Study
|
N/A | |
Not yet recruiting |
NCT05556460 -
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
|
N/A | |
Recruiting |
NCT05667519 -
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
|
N/A | |
Recruiting |
NCT04653428 -
German Registry for Transcatheter Tricuspid Valve Interventions
|
||
Recruiting |
NCT05179616 -
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
|
||
Completed |
NCT02644616 -
The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement
|
Phase 4 | |
Recruiting |
NCT05328284 -
PASCAL for Tricuspid Regurgitation - a European Registry
|
||
Completed |
NCT02675244 -
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
|
N/A | |
Recruiting |
NCT05436028 -
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
|
N/A | |
Completed |
NCT01093001 -
Tricuspid Regurgitation Study
|
Phase 4 |