Vericiguat for small-vessel (microvascular) heart disease causing stable chest pain

Randomised Controlled Trial of Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)

This trial gives vericiguat to people aged 40–75 with chest pain from coronary microvascular dysfunction to see if it improves blood flow in the heart on stress CMR.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: The University of Hong Kong (Academic / other)
• Locations: 1 site (Hong Kong)
• Trial ID: NCT06239974 on ClinicalTrials.gov

What this trial studies

This is a randomized controlled trial at The University of Hong Kong testing vericiguat against a control to improve myocardial blood flow and myocardial perfusion reserve measured by stress cardiac magnetic resonance imaging. Eligible participants have stable recurrent chest pain, non-obstructive coronary arteries on recent CT or catheter angiogram, and reduced stress MBF or MPR below the specified cutoff. Key exclusions include low systolic blood pressure and concurrent use of other soluble guanylate cyclase stimulators or phosphodiesterase-5 inhibitors. The primary endpoints are quantitative CMR measures of stress myocardial blood flow and perfusion reserve to determine whether vericiguat improves microvascular perfusion.

Who should consider this trial

Good fit: Adults 40–75 years old with stable recurrent chest pain, non-obstructive coronary arteries on angiography or CT within 6 months, and abnormal stress CMR with MPR or MBF below the trial cutoff are ideal candidates.

Not a fit: Patients with obstructive coronary disease, alternative non-cardiac causes of chest pain, low systolic blood pressure, or who cannot stop nitrates or PDE5 inhibitors are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, vericiguat could improve blood flow through the coronary microvasculature and reduce ischemic symptoms in patients with microvascular dysfunction.

How similar studies have performed: Vericiguat has shown clinical benefit in heart failure populations, but using soluble guanylate cyclase stimulation specifically to improve coronary microvascular blood flow is largely novel and has limited prior clinical data.

Eligibility criteria

Inclusion Criteria:

1. Stable recurrent chest pain.
2. 40 to 75 years old.
3. 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).
4. Stress CMR MPR \<2.19 12 or Stress MBF \<2.19ml/g/min 13.
5. 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.

Exclusion Criteria:

1. Systolic blood pressure \<100 mm Hg.
2. Concurrent use of soluble guanylate cyclase stimulators (eg. Riociguat), or phosphodiesterase type 5 inhibitors (eg. vardenafil, tadalafil, and sildenafil).
3. Has known allergy or sensitivity to any soluble guanylate cyclase stimulator.
4. On long-acting nitrates (eg. isosorbide mononitrate)
5. Known cardiomyopathy, complex congenital heart disease, endocarditis or pericarditis.
6. 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.
7. Has symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days prior to randomisation.
8. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2
9. Malignancy or other non-cardiac condition limiting life expectancy to \<3 years.
10. Patient's with implanted devices which are not MRI compatible.

Where this trial is running

Hong Kong

• The University of Hong Kong — Hong Kong, Hong Kong (Recruiting)

Conditions Chest Pain; Stress Cardiac Magnetic Resonance