Chest PainNCT06239974
Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)
A study testing Vericiguat and Stress Cardiac Magnetic Resonance in people with Chest Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a randomised controlled trial to determine the effectiveness of Vericiguat to improve stress myocardial blood flow (MBF) and myocardial perfusion reserve as measured by cardiac magnetic resonance (CMR) imaging. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chest Pain
- What is being tested?
- Vericiguat and Stress Cardiac Magnetic Resonance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable recurrent chest pain.
- 40 to 75 years old.
- Have coronary computed tomography (CT) angiogram or catheter coronary angiogram within 6 months showing non-obstructive coronary artery disease (<50% coronary artery stenosis or fractional flow reserve >0.8).
- Stress CMR MPR <2.19 12 or Stress MBF <2.19ml/g/min 13.
- Female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP),or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.
Who cannot join
- Systolic blood pressure <100 mm Hg.
- Concurrent use of soluble guanylate cyclase stimulators (eg. Riociguat), or phosphodiesterase type 5 inhibitors (eg. vardenafil, tadalafil, and sildenafil).
- Has known allergy or sensitivity to any soluble guanylate cyclase stimulator.
- On long-acting nitrates (eg. isosorbide mononitrate)
- Known cardiomyopathy, complex congenital heart disease, endocarditis or pericarditis.
- Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction (NSTEMI), or ST elevation myocardial infarction (STEMI)) or coronary revascularization (coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)) within 60 days prior to randomisation, or indication for coronary revascularization at time of randomisation.
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- Has symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days prior to randomisation.
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- Malignancy or other non-cardiac condition limiting life expectancy to <3 years.
- Patient's with implanted devices which are not MRI compatible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Ming Yen Ng, BMBS, (852)22554524, myng2@hku.hk
About this study
Official title: Randomised Controlled Trial of Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)
This is a randomised controlled trial to determine the effectiveness of Vericiguat to improve stress myocardial blood flow (MBF) and myocardial perfusion reserve as measured by cardiac magnetic resonance (CMR) imaging.
Read the detailed description
Stable chest pain is one of the most common complaints by patients. However, about 50% of patients referred for catheter coronary angiograms do not have obstructive coronary artery disease (CAD). In the United Kingdom (UK), one very large population study showed that ~70% of patients did not have a cause for the chest pain diagnosed within 6 months of presentation. Furthermore, the study further showed that this group of patients had a significantly higher risk of major adverse cardiovascular events (MACE) compared to patients without chest pain. It is now understood that the two major causes of cardiac chest pain with non obstructive CAD (also known as Ischaemia with Non Obstructive Coronary Arteries (INOCA)) are coronary microvascular dysfunction (CMD) and the other is coronary vasospasm. CMD and coronary vasospasm have been shown in one randomised controlled study to comprise 52% and 17% of all patients with INOCA. However, therapies for CMD are lacking and has been highlighted as a major area of need.
- Conditions
- Chest Pain
- Being tested
- Vericiguat, Stress Cardiac Magnetic Resonance
- Keywords
- Stress Cardiac Magnetic Resonance
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
Also called Verquvo
Patients will be prescribed vericiguat once a day for 6 months, starting at 2.5mg and titrated up to the full dose of 10mg per day (doubling of dose every 2 weeks) in addition to optimised medical therapy and standard follow-up like the control group
Stress Cardiac Magnetic ResonanceDiagnostic test
Also called Stress CMR
All patients will have stress CMR examinations at recruitment and at the end of trial.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will have no intervention and will continue to have optimised medical therapy and follow-up appointments (currently 1 appointment every 3 months). Receives: Diagnostic Test: Stress Cardiac Magnetic Resonance |
| Intervention group | Experimental | Patients will be prescribed vericiguat once a day for 6 months, starting at 2.5mg and titrated up to the full dose of 10mg per day (doubling of dose every 2 weeks) in addition to optimised medical therapy and standard follow-up like the control group Receives: Drug: Vericiguat; Diagnostic Test: Stress Cardiac Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in stress myocardial blood flow (MBF)
Difference in stress MBF as measured by stress CMR between patients receiving Vericiguat and patients not receiving Vericiguat
Measured: 36 months
Difference in stress myocardial perfusion reserve (MPR)
Difference in stress MPR as measured by stress CMR between patients receiving Vericiguat and patients not receiving Vericiguat
Measured: 36 months
Secondary outcomes (2)
Improvement in exercise tolerance through performing a cardiopulmonary exercise test.
Measured by baseline and end of study 6-minute walk test
Measured: 36 months
Progression in patient symptoms diagnoses.
The Seattle Angina Questionnaire (SAQ-7) scores are transformed to a range of 0-100, in which higher scores reflect better health status. The measurement will take place at time of baseline CMR and at follow-up CMR in order to determine if there is an improvement in patient symptoms.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Sep 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239974
- Sponsor's protocol ID
- UW 23-605
- Status last verified
- Jun 2026
- First submitted
- 25 Jan 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)
- ClinicalTrials.gov ID
- NCT06239974
- Acronym / sponsor ID
- UW 23-605
- Conditions
- Chest Pain
- Keywords
- Stress Cardiac Magnetic Resonance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 2 Feb 2024 (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.
This is a randomised controlled trial to determine the effectiveness of Vericiguat to improve stress myocardial blood flow (MBF) and myocardial perfusion reserve as measured by cardiac magnetic resonance (CMR) imaging.
Detailed description
Stable chest pain is one of the most common complaints by patients. However, about 50% of patients referred for catheter coronary angiograms do not have obstructive coronary artery disease (CAD). In the United Kingdom (UK), one very large population study showed that ~70% of patients did not have a cause for the chest pain diagnosed within 6 months of presentation. Furthermore, the study further showed that this group of patients had a significantly higher risk of major adverse cardiovascular events (MACE) compared to patients without chest pain. It is now understood that the two major causes of cardiac chest pain with non obstructive CAD (also known as Ischaemia with Non Obstructive Coronary Arteries (INOCA)) are coronary microvascular dysfunction (CMD) and the other is coronary vasospasm. CMD and coronary vasospasm have been shown in one randomised controlled study to comprise 52% and 17% of all patients with INOCA. However, therapies for CMD are lacking and has been highlighted as a major area of need.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blinded Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Diagnostic Test: Stress Cardiac Magnetic ResonancePatients will have no intervention and will continue to have optimised medical therapy and follow-up appointments (currently 1 appointment every 3 months). |
| Intervention group | Experimental | Drug: Vericiguat, Diagnostic Test: Stress Cardiac Magnetic ResonancePatients will be prescribed vericiguat once a day for 6 months, starting at 2.5mg and titrated up to the full dose of 10mg per day (doubling of dose every 2 weeks) in addition to optimised medical therapy and standard follow-up like the control group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable recurrent chest pain.
- 40 to 75 years old.
- Have coronary computed tomography (CT) angiogram or catheter coronary angiogram within 6 months showing non-obstructive coronary artery disease (<50% coronary artery stenosis or fractional flow reserve >0.8).
- Stress CMR MPR <2.19 12 or Stress MBF <2.19ml/g/min 13.
- Female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP),or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.
Key exclusion criteria (10 listed)
- Systolic blood pressure <100 mm Hg.
- Concurrent use of soluble guanylate cyclase stimulators (eg. Riociguat), or phosphodiesterase type 5 inhibitors (eg. vardenafil, tadalafil, and sildenafil).
- Has known allergy or sensitivity to any soluble guanylate cyclase stimulator.
- On long-acting nitrates (eg. isosorbide mononitrate)
- Known cardiomyopathy, complex congenital heart disease, endocarditis or pericarditis.
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 |
|---|---|---|
| VericiguatAlso: VerquvoPatients will be prescribed vericiguat once a day for 6 months, starting at 2.5mg and titrated up to the full dose of 10mg per day (doubling of dose every 2 weeks) in addition to optimised medical therapy and standard follow-up like the control group | Drug | Intervention group |
| Stress Cardiac Magnetic ResonanceAlso: Stress CMRAll patients will have stress CMR examinations at recruitment and at the end of trial. | Diagnostic test | Control group, Intervention group |
Primary outcome
Difference in stress myocardial blood flow (MBF)
Time frame: 36 months
Difference in stress MBF as measured by stress CMR between patients receiving Vericiguat and patients not receiving Vericiguat
Difference in stress myocardial perfusion reserve (MPR)
Time frame: 36 months
Difference in stress MPR as measured by stress CMR between patients receiving Vericiguat and patients not receiving Vericiguat
2 secondary outcomes
Improvement in exercise tolerance through performing a cardiopulmonary exercise test.
Time frame: 36 months
Progression in patient symptoms diagnoses.
Time frame: 36 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 29 Jun 2026.
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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 study testing Vericiguat and Stress Cardiac Magnetic Resonance in people with Chest Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 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 Hong Kong. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in stress myocardial blood flow (MBF) (time frame: 36 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?
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 29 Jun 2026.