Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
Study Overview
Brief Summary
The goal of this clinical trial is to learn if the drug vericiguat works to improve right heart function in patients with worsening heart failure who have reduced left ventricular function. It will also examine the effects of the drug on tricuspid regurgitation (TR) and overall clinical outcomes.
The main questions it aims to answer are:
Does vericiguat improve right ventricular (RV) function and reduce tricuspid regurgitation (TR)? Does vericiguat reduce the risk of major adverse cardiovascular events (MACE), such as heart failure hospitalizations and cardiovascular death? Does vericiguat improve participants' exercise capacity, quality of life, and renal function?
Researchers have previously seen the benefits of vericiguat in the large-scale VICTORIA trial for worsening heart failure, and it is hypothesized that improvements in right heart function play a key role. This study aims to confirm these specific benefits.
Participants will:
Take vericiguat as prescribed during the study period. Undergo echocardiograms at enrollment and at 9 months to assess right heart function.
Complete questionnaires (KCCQ-12) and walking tests (6MWT) to evaluate quality of life and exercise capacity.
Provide blood samples to monitor NTproBNP levels and renal function (creatinine).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age more than 19 years old
- •right ventricular malfunction confirmed with EKG data or cardiac MRI
- •chronic heart failure with LVEF<45%
- •Patients Who administrated standard treatment of Heart Failur for over the 4 weeks
- •NTproBNP >1000, NTproBNP >1600 with atrial fibrillation or The patient who recently experienced worsening heart failure(Recent hospitalization for worsening heart failure or outpatient administration of intravenous diuretics)
- •Tricuspid regurgitation of greater than moderate severity was confirmed by echocardiogram
- •Subject who provided voluntary informed consent to participate in the study
- •Patients who have not been administered vericiguat within the last 6 months
Exclusion Criteria
- •Patients with a systolic blood pressure (SBP) < 100 mmHg
- •Patients currently treated with other sGC stimulators (including vericiguat) or phosphodiesterase-5 (PDE5) inhibitors
- •Moderate-to-severe right ventricular (RV) failure requiring surgical intervention
- •Patients who are currently pregnant or of childbearing potential
Investigators
Jung Sun Cho
Primary Investigator
Daejeon St. Mary's hospital