HFrEF, Tricuspid Regurgitation (TR)
Conditions
Keywords
HFrEF, TR, Vericiguat
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).
Interventions
DRUGVericiguat
Participants will start vericiguat at 2.5 mg once daily, and the dose will be gradually uptitration every 2 weeks to a target dose of 10 mg once daily, depending on tolerability.
Sponsors
Daejeon St. Mary's hospital
Seoul St. Mary's Hospital
Uijeongbu St. Mary Hospital
Incheon St.Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
arm 1- intervention \[drug\] vericiguat , arm2- \[other\] standard medical therpay
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age more than 19 years old 2. right ventricular malfunction confirmed with EKG data or cardiac MRI 3. chronic heart failure with LVEF\<45% 4. Patients Who administrated standard treatment of Heart Failur for over the 4 weeks 5. 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) 6. Tricuspid regurgitation of greater than moderate severity was confirmed by echocardiogram 7. Subject who provided voluntary informed consent to participate in the study 8. Patients who have not been administered vericiguat within the last 6 months
Exclusion criteria
1. Patients with a systolic blood pressure (SBP) \< 100 mmHg 2. Patients currently treated with other sGC stimulators (including vericiguat) or phosphodiesterase-5 (PDE5) inhibitors 3. Moderate-to-severe right ventricular (RV) failure requiring surgical intervention 4. Patients who are currently pregnant or of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NTproBNP | NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months. | — |
| Echocardiographic RV function parameters | From enrollment to the end of treatment at baseline and 9 months | RVSP, RV volume, TAPSE, RV strain/PAP, TR grade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of Major Adverse Cardiovascular Events (MACE) | From enrollment to the end of treatment at 9 months | Composite endpoint of Major Adverse Cardiovascular Events (MACE), including hospitalization for heart failure (requiring a minimum of 24 hours of hospitalization and intravenous diuretic therapy) and cardiovascular death. |
| Exercise capacity and quality of life | From enrollment to the end of treatment at baseline and 9 months | Kansas City Cardiomyopathy Questionnaire (KCCQ-12) |
| 6-Minute Walk Test (6MWT distance) | From enrollment to the end of treatment at baseline and 9 months | 6-Minute Walk Test (6MWT distance) |
| Renal Function | from enrollment to the end of treatment at baseline, 3 and 9 months. | Renal function: Serum creatinine (Cr) |
Countries
South Korea
Contacts
CONTACTPrincipal Investigator
Outcome results
None listed