HFrEFPhase 4VERT-HFNCT07668739
Efficacy of Verciguat in TR and RV Failure
A Phase 4 study testing Vericiguat in people with HFrEF and Tricuspid Regurgitation (TR), run by Daejeon St. Mary's hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HFrEF, Tricuspid Regurgitation (TR)
- What is being tested?
- Vericiguat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2026to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Daejeon St.Mary's Hospital
Daejeon, 34943
Principle Investigator, +82-42-220-9943, tworugi@daum.net
About this study
Official title: 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:
Read more
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)
- Being tested
- Vericiguat
- Keywords
- HFrEF, TR, Vericiguat
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NTproBNP
Measured: 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
Measured: From enrollment to the end of treatment at baseline and 9 months
Secondary outcomes (4)
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.
Measured: From enrollment to the end of treatment at 9 months
Exercise capacity and quality of life
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Measured: From enrollment to the end of treatment at baseline and 9 months
6-Minute Walk Test (6MWT distance)
6-Minute Walk Test (6MWT distance)
Measured: From enrollment to the end of treatment at baseline and 9 months
Renal Function
Renal function: Serum creatinine (Cr)
Measured: from enrollment to the end of treatment at baseline, 3 and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HFrEFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- arm 1- intervention \[drug\] vericiguat , arm2- \[other\] standard medical therpay
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daejeon St. Mary's hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Uijeongbu St. Mary Hospital, Incheon St.Mary's Hospital
- Responsible party
- Principal investigator, Jung Sun Cho, Daejeon St. Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668739
- Sponsor's protocol ID
- DC26MIDI0013
- Acronym
- VERT-HF
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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, 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.
PubMed 37208936Hashimoto 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.
PubMed 39134125
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vericiguat in HFrEF Patients With Coexisting Severe Tricuspid Regurgitation and Right Heart Failure; Multicenter Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07668739
- Acronym / sponsor ID
- VERT-HF / DC26MIDI0013
- Conditions
- HFrEF, Tricuspid Regurgitation (TR)
- Keywords
- HFrEF, TR, Vericiguat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Daejeon St. Mary's hospitalUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Uijeongbu St. Mary Hospital, Incheon St.Mary's Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- arm 1- intervention [drug] vericiguat , arm2- [other] standard medical therpay
| Arm | Type | Receives |
|---|---|---|
| Arm with administered with Vericiguat | Experimental | Drug: VericiguatSubjects 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. |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatParticipants 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. | Drug | Arm with administered with Vericiguat |
Primary outcome
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
RVSP, RV volume, TAPSE, RV strain/PAP, TR grade
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 37208936Metra 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.
- Results publication: PubMed 39134125Hashimoto 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.
- Individual participant dataSharing planned: Undecided
Related trials for HFrEF
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingPhase 1
A Study of LY3971297 in Participants With Heart Failure
Heart Failure, Heart Failure, Diastolic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vericiguat in people with HFrEF and Tricuspid Regurgitation (TR), run by Daejeon St. Mary's hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (+82-42-220-9943, tworugi@daum.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NTproBNP (time frame: NTproBNP will be assessed from enrollment to the end of treatment at baseline, 3 and 9 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668739, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.