Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image (UMPIRE)
Microvascular Angina
About this trial
This is an interventional treatment trial for Microvascular Angina focused on measuring microvascular angina, PDE-5 inhibitors, Heart disease, Ischemia, Cardiac MRI
Eligibility Criteria
Inclusion Criteria:
- MVA patients with typical symptom and positive adenosine-stress cardiac MRI and with normal coronary artery in coronary angiogram or coronary artery CT angiography.
- Definition of positive adenosine-stress MRI: perfusion defect > 25% of transmurality ( by 2 radiologist based on visual assessment and qualitative assessment in core-lab)
- Gender: female
- Age: 18-80
Exclusion Criteria:
- The patient with contraindication to MR contrast media or MR Imaging
- LVEF < 50%
- Any heart rhythm abnormality other than sinus rhythm
- Valvular heart disease with more than moderate degree
- Renal failure
- Congestive Heart Failure
- Myocardial infraction
- Myocarditis
- Congenital heart disease
- Pericarditis
- Variant angina (positive provocation test with Ergonovine or acetylcholine)
- GERD (conformed by esophagogastroduodenoscopy)
- Pregnant women with suspected, pregnant women or women with lactation
- QT prolongation syndrome or take drugs that prolong the QT interval - Antiarrhythmics class IA; quinidine, procainamide - Antiarrhythmics class III; amiodarone, sotalol
Preanalytical within 30 days of screening in a clinical trial that may affect the influence of udenafil
- Other PDE5 inhibitors (ex. Sildenafil, tadalafil)
- Nitrates/ NO donor (ex. Nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrate/nitrite, sodium nitroprusside, nicorandil)
Preanalytical within 7 days of screening in a clinical trial that may affect the metabolism of udenafil
- Antibacterials (ex. Erythromycin)
- Antifungals (ex. Itraconazole, ketoconazole)
- Antivirals (ex. Ritonavir, saquinavir, amprenavir, indinavir, nelfinavir)
- Cimetidine
- Grapefruit juice
Allergy or sensitivity with PDE 5 inhibitors
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Sites / Locations
- Seoul National University Bundang HospitalRecruiting
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Udenafil
Placebo
70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg or placebo po q d for 3 months.
70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg or placebo po q d for 3 months.