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| Name | Class |
|---|---|
| Seoul St. Mary's Hospital | OTHER |
| Uijeongbu St. Mary Hospital | OTHER |
| Incheon St.Mary's Hospital | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm with administered with Vericiguat | Experimental | Subjects assigned to the experimental arm will initiate vericiguat at a daily dose of 2.5 mg, concurrently with their baseline heart failure therapy including standard of care (loop diuretics, MRAs, and SGLT2i). The dose will be targeted to double every 2 weeks, titrating up to a maximum dose of 10 mg. |
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| Arm with standard of care | No Intervention | This arm is classified as the standard of care control group, where participants receive baseline heart failure therapies including loop diuretics, MRAs, and SGLT2i. During the study period, if a participant in this arm exhibits no symptomatic improvement or demonstrates clinical worsening despite baseline therapy, the investigator will re-evaluate the doses of the existing standard medications and titrate them up to the maximum recommended doses within a permissible range, or adjust the medication combination to prioritize patient safety. Additionally, in cases of accompanied fluid overload, further pharmacological interventions, including the adjustment of diuretics, may be administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| NTproBNP | NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months. | |
| Echocardiographic RV function parameters | RVSP, RV volume, TAPSE, RV strain/PAP, TR grade | From enrollment to the end of treatment at baseline and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint of Major Adverse Cardiovascular Events (MACE) | 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. | From enrollment to the end of treatment at 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | +82-42-220-9943 | tworugi@daum.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejeon St.Mary's Hospital | Daejeon | 34943 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37208936 | Result | 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, Vitale C, Volterrani M, von Haehling S, Chioncel O, Coats AJS, Rosano G. Worsening of chronic heart failure: definition, epidemiology, management and prevention. A clinical consensus statement by the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2023 Jun;25(6):776-791. doi: 10.1002/ejhf.2874. Epub 2023 May 19. | |
| 39134125 |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
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arm 1- intervention [drug] vericiguat , arm2- [other] standard medical therpay
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| Exercise capacity and quality of life |
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) |
| From enrollment to the end of treatment at baseline and 9 months |
| 6-Minute Walk Test (6MWT distance) | 6-Minute Walk Test (6MWT distance) | From enrollment to the end of treatment at baseline and 9 months |
| Renal Function | Renal function: Serum creatinine (Cr) | from enrollment to the end of treatment at baseline, 3 and 9 months. |
| Result |
| 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. |