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

NCT06239974 | Recruiting

• 1 other identifier: UW 23-605
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chest Pain

Keywords

Stress Cardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (2)

• 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

  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

  36 months

Secondary Outcomes (2)

• Improvement in exercise tolerance through performing a cardiopulmonary exercise test.

  36 months

• Progression in patient symptoms diagnoses.

  36 months

Study Arms (2)

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).

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

Drug: Vericiguat; Diagnostic Test: Stress Cardiac Magnetic Resonance

Interventions

Vericiguat DRUG

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

Also known as: Verquvo

Intervention group

Stress Cardiac Magnetic Resonance DIAGNOSTIC_TEST

All patients will have stress CMR examinations at recruitment and at the end of trial.

Also known as: Stress CMR

Control group; Intervention group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Chest Pain

Interventions

vericiguat

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Cardiovascular Magnetic Resonance Level 3 radiologists will be blinded to the patient allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blinded Randomised Controlled Trial

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)