Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)
Randomised Controlled Trial of Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)
The University of Hong Kong
94 participants
Sep 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Stable recurrent chest pain.
- 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.
Exclusion Criteria10
- 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.
- 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.
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Interventions
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
All patients will have stress CMR examinations at recruitment and at the end of trial.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06239974