Efficacy of Verciguat in TR and RV Failure

NCT07668739 | Not Yet Recruiting Phase 4

• 1 other identifier: DC26MIDI0013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

HFrEF; Tricuspid Regurgitation (TR)

Keywords

HFrEF; TR; Vericiguat

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Composite endpoint of Major Adverse Cardiovascular Events (MACE)

  From enrollment to the end of treatment at 9 months

• Exercise capacity and quality of life

  From enrollment to the end of treatment at baseline and 9 months

• 6-Minute Walk Test (6MWT distance)

  From enrollment to the end of treatment at baseline and 9 months

• Renal Function

  from enrollment to the end of treatment at baseline, 3 and 9 months.

Study Arms (2)

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.

Drug: Vericiguat

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.

Interventions

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.

Arm with administered with Vericiguat

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daejeon St. Mary's hospital: lead
• Seoul St. Mary's Hospital: collaborator
• Uijeongbu St. Mary Hospital: collaborator
• Incheon St.Mary's Hospital: collaborator

Study Sites (1)

Daejeon St.Mary's Hospital

Daejeon, 34943, South Korea

Location

Related Publications (2)

• 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.

  PMID: 37208936 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.

  PMID: 39134125 RESULT

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Principal Investigator

CONTACT

+82-42-220-9943; tworugi@daum.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: arm 1- intervention \[drug\] vericiguat , arm2- \[other\] standard medical therpay

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Locations

KR (1)