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NCT Number: NCT07668739

Efficacy of Verciguat in TR and RV Failure

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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Key information

Conditions

HFrEF Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Regurgitation (TR) Tricuspid Valve Insufficiency

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. NTproBNP

    Time frame: NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.

  2. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. Renal Function

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

    Renal function: Serum creatinine (Cr)

Study contacts

Contact information is provided by the study sponsor or research team.

Principal Investigator

CONTACT

[email protected]

+82-42-220-9943

Sponsors and collaborators

Lead sponsor

Daejeon St. Mary's hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: VERT-HF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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