Efficacy of Verciguat in TR and RV Failure

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorDaejeon St. Mary's hospital

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Vericiguat

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Daejeon St. Mary's hospital

Lead sponsor

Seoul St. Mary's Hospital

Collaborator

Uijeongbu St. Mary Hospital

Collaborator

Incheon St.Mary's Hospital

Collaborator