Chest Pain
Conditions
Keywords
Stress Cardiac Magnetic Resonance
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.
Detailed description
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.
Interventions
DRUGVericiguat
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
DIAGNOSTIC_TESTStress Cardiac Magnetic Resonance
All patients will have stress CMR examinations at recruitment and at the end of trial.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Cardiovascular Magnetic Resonance Level 3 radiologists will be blinded to the patient allocation.
Intervention model description
Single-blinded Randomised Controlled Trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in stress myocardial blood flow (MBF) | 36 months | Difference in stress MBF as measured by stress CMR between patients receiving Vericiguat and patients not receiving Vericiguat |
| Difference in stress myocardial perfusion reserve (MPR) | 36 months | Difference in stress MPR as measured by stress CMR between patients receiving Vericiguat and patients not receiving Vericiguat |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in exercise tolerance through performing a cardiopulmonary exercise test. | 36 months | Measured by baseline and end of study 6-minute walk test |
| Progression in patient symptoms diagnoses. | 36 months | 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. |
Countries
Hong Kong
Outcome results
None listed