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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The University of Hong Kong
  Hong Kong, Hong Kong Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.