Pharmacological Reduction of Right Ventricular Enlargement

Sponsor
Asan Medical Center
Study ID
NCT04345796
Phase
PHASE3
Status
Completed

Conditions

  • Right Ventricular Dilatation
  • Tricuspid Regurgitation

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 15, 2021
Status verified
Apr 2025
Primary completion
Jun 3, 2024
Completion
Jun 3, 2024

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: carvedilol+empagliflozin
    Patients will receive carvedilol SR 16mg and empagliflozin 10mg qd.
  • Active Comparator: carvedilol alone
    Patients will receive carvedilol SR 16mg alone.
  • Active Comparator: empagliflozin alone
    Patients will receive empagliflozin 10mg and matching placebo of carvedilol.
  • Placebo Comparator: placebo
    Patients will receive matching placebo of carvedilol.

Primary Outcome Measure

Change of RV end-systolic volume index [ Time Frame: from baseline to 12 months follow-up ]

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