None listed
Conditions
Brief summary
A large proportion of INOCA (ischaemia with non-obstructive coronary arteries) patients continue to have symptoms despite being on multiple medications. Sildenafil was studied in a small international study in 2011 which showed some early promising results. However, to the best of our knowledge, there have been no subsequent studies using Sildenafil to treat INOCA. The purpose of this study is to see if Sildenafil improves INOCA symptoms.
Interventions
Participants will be randomised to sildenafil 50mg oral tablet twice daily and placebo in 1:1 fashion for a total of 8 weeks. They will have regular follow-up visits and verbal confirmation to assess adherence. All participants will undergo treadmill exercise stress testing at baseline and at the end of drug intervention. All participants will undergo coronary angiography with comprehensive physiology testing upon completion of drug intervention.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age >18 - Non-obstructive coronary artery disease (CAD) - Confirmed diagnosis of vasospastic and/or microvascular angina on previous functional coronary angiography (defined as: CFR < 2.5 and/or IMR > 25 and/or epicardial and/or microvascular spasm) - >2 angina episodes per week despite maximally tolerated standard anti-anginal therapy
Exclusion criteria
- Previous intolerance to PDE-5 inhibitors due to drug adverse effects - Pregnant or breastfeeding women - Renal impairment (eGFR < 30mL/min) - Severe valvular heart disease - Previous priaprism - Blood pressure < 90/60mmHg or >170/110mmHg - Severe hepatic impairment - Recent stroke or myocardial infarction - Sickle cell disease - Concurrent use of green tea extract - Known hereditary degenerative retinal disorders (eg Retiniis pigmentosa) - Contraindications to functional coronary angiography
Outcome results
None listed