Table 2.
Inclusion criteria | |
1 | MVA patients with typical symptom and positive adenosine-stress CMR and with normal coronary artery in CCTA or coronary angiography. |
2 | Definition of positive adenosine-stress CMR: perfusion defect >25% of transmurality (by two radiologists based on visual assessment and qualitative assessment in core-lab) |
3 | Gender: female |
4 | Age: 18 to 80-years-old |
Exclusion criteria | |
1 | Patient has a contraindication to CMR contrast media or CMR imaging |
2 | LVEF <50% |
3 | Any heart rhythm abnormality other than sinus rhythm |
4 | Valvular heart disease with more than moderate degree |
5 | Renal failure |
6 | Congestive heart failure |
7 | Myocardial infraction |
8 | Myocarditis |
9 | Congenital heart disease |
10 | Pericarditis |
11 | Variant angina (positive provocation test with ergonovine or acetylcholine) |
12 | GERD (conformed by esophagogastroduodenoscopy) |
13 | Pregnant women, suspected pregnant women or lactating women |
14 | QT prolongation syndrome or taking drugs that prolong the QT interval: |
- Antiarrhythmics class IA; quinidine, procainamide | |
- Antiarrhythmics class III; amiodarone, sotalol | |
15 | Pre-analytical within 30 days of screening in a clinical trial that may affect the influence of udenafil: |
- Other PDE-5 inhibitors (for example sildenafil, tadalafil) | |
- Nitrates/NO donor (for example nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, sodium nitroprusside, and nicorandil) | |
16 | Pre-analytical within seven days of screening in a clinical trial that may affect the metabolism of udenafil: |
- Antibacterials (for example erythromycin) | |
- Antifungals (for example itraconazole, ketoconazole) | |
- Antivirals (for example ritonavir, saquinavir, amprenavir, indinavir, nelfinavir) | |
- Cimetidine | |
- Grapefruit juice | |
17 | Allergy or sensitivity with PDE-5 inhibitors |
CCTA; Coronary CT angiography, CMR; Cardiac magnetic resonance image, GERD; Gastroesophageal reflux disorder, LVEF; Left ventricular ejection fraction, MVA; Microvascular angina, NO; Nitric oxide, PDE-5; Phosphodiesterase-5.