Efficacy of Verciguat in TR and RV Failure (VERT-HF)

June 23, 2026 updated by: Jung Sun Cho, Daejeon St. Mary's hospital

Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled 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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Principal Investigator
  • Phone Number: +82-42-220-9943
  • Email: tworugi@daum.net

Study Locations

  • South Korea
      • Daejeon, South Korea, 34943
        • Daejeon St.Mary's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm with administered with Vericiguat
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
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.
No Intervention: Arm with standard of care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NTproBNP
Time Frame: NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.
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
RVSP, RV volume, TAPSE, RV strain/PAP, TR grade
From enrollment to the end of treatment at baseline and 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of Major Adverse Cardiovascular Events (MACE)
Time Frame: 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.
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
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
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
6-Minute Walk Test (6MWT distance)
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.
Renal function: Serum creatinine (Cr)
from enrollment to the end of treatment at baseline, 3 and 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daejeon St. Mary's hospital

Collaborators

Seoul St. Mary's Hospital
Incheon St.Mary's Hospital
Uijeongbu St. Mary Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC26MIDI0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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