Efficacy of Verciguat in TR and RV Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vericiguat.
- Who it may be relevant to
- Registry conditions: HFrEF, Tricuspid Regurgitation (TR). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled Trial
Overview
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
- Drug Vericiguat
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.
Primary outcome measures
- NTproBNP [Time frame: NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.]
- Echocardiographic RV function parameters [Time frame: From enrollment to the end of treatment at baseline and 9 months]
Secondary outcome measures (4)
- Composite endpoint of Major Adverse Cardiovascular Events (MACE) [Time frame: From enrollment to the end of treatment at 9 months]
- Exercise capacity and quality of life [Time frame: From enrollment to the end of treatment at baseline and 9 months]
- 6-Minute Walk Test (6MWT distance) [Time frame: From enrollment to the end of treatment at baseline and 9 months]
- Renal Function [Time frame: from enrollment to the end of treatment at baseline, 3 and 9 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Daejeon St.Mary's Hospital — Daejeon
Publications
- Metra M, Tomasoni D, Adamo M, Bayes-Genis A, Filippatos G, Abdelhamid M, Adamopoulos S, Anker SD, Antohi L, Bohm M, Braunschweig F, Gal TB, Butler J, Cleland JGF, Cohen-Solal A, Damman K, Gustafsson F, Hill L, Jankowska EA, Lainscak M, Lund LH, McDonagh T, Mebazaa A, Moura B, Mullens W, Piepoli M, Ponikowski P, Rakisheva A, Ristic A, Savarese G, Seferovic P, Sharma R, Tocchetti CG, Yilmaz MB, Vita PMID 37208936
- Hashimoto T, Yoshitake T, Suenaga T, Yamamoto S, Fujino T, Shinohara K, Matsushima S, Ide T, Kinugawa S, Abe K. Effectiveness of Vericiguat on right ventricle to pulmonary artery uncoupling associated with heart failure with reduced ejection fraction. Int J Cardiol. 2024 Nov 15;415:132441. doi: 10.1016/j.ijcard.2024.132441. Epub 2024 Aug 10. PMID 39134125
Identifiers
NCT: NCT07668739 · DC26MIDI0013