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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.
Stable chest pain is one of the most common complaints by patients. However, about 50% of patients referred for catheter coronary angiograms do not have obstructive coronary artery disease (CAD). In the United Kingdom (UK), one very large population study showed that ~70% of patients did not have a cause for the chest pain diagnosed within 6 months of presentation. Furthermore, the study further showed that this group of patients had a significantly higher risk of major adverse cardiovascular events (MACE) compared to patients without chest pain. It is now understood that the two major causes of cardiac chest pain with non obstructive CAD (also known as Ischaemia with Non Obstructive Coronary Arteries (INOCA)) are coronary microvascular dysfunction (CMD) and the other is coronary vasospasm. CMD and coronary vasospasm have been shown in one randomised controlled study to comprise 52% and 17% of all patients with INOCA. However, therapies for CMD are lacking and has been highlighted as a major area of need.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in exercise tolerance through performing a cardiopulmonary exercise test. | Measured by baseline and end of study 6-minute walk test | 36 months |
| Progression in patient symptoms diagnoses. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000603960 | vericiguat |
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Single-blinded Randomised Controlled Trial
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Cardiovascular Magnetic Resonance Level 3 radiologists will be blinded to the patient allocation.
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| Stress Cardiac Magnetic Resonance | Diagnostic Test | All patients will have stress CMR examinations at recruitment and at the end of trial. |
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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.
| 36 months |