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

ConditionChest Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorThe University of Hong Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • Stress Cardiac Magnetic Resonance

    Diagnostic test

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

Treatment groups

94 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
36 months
2

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

Time frame
36 months

Secondary outcomes

1

Improvement in exercise tolerance through performing a cardiopulmonary exercise test.

Measured by baseline and end of study 6-minute walk test

Time frame
36 months
2

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.

Time frame
36 months

Other outcomes

Sponsors and contacts

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