Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image

Microvascular Angina Clinical Trial

— UMPIRE  

Official title:

Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01769482
• Other study ID #: 2011-07-048
• Status: Recruiting
• Phase: Phase 4
• First received: November 20, 2012
• Last updated: March 24, 2014
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2012
• Source: Samsung Medical Center
• Contact: Sung-Ji Park, M.D.,Ph.D.
• Phone: 82-2-3410-0887
• Email: tyche.park[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Current therapeutic options for a well-recognized group of patients with anginal symptoms—a positive exercise tolerance testing, SPECT or perfusion defect in MRI but angiographically normal coronary arteries—are limited. The condition, referred to as microvascular angina (MVA) or cardiac syndrome X, is not as benign as originally reported—patients presenting with unstable angina and nonobstructive atherosclerotic coronary artery disease have a 2% risk of death or myocardial infarction at 30 days of follow-up. It is more common in women in whom the first presentation of angina occurs either perimenopausally or postmenopausally. Aberrant flow-mediated coronary vasomotion is pivotal in the pathogenesis (systemic) impairment in endothelial function. Indeed, some centers use systemic assessments of vascular function in their diagnostic pathways for this group of women. It was recently suggested that endothelial dysfunction may lead to myocardial ischemia.

In the present study, the investigators tested the hypothesis that udenafil offers dual benefits of improving vascular function and lessening ischemia in women with angina, perfusion defect in cardiac MRI, and normal coronary arteries.

Description:

The aim of this study is that udenafil offers dual benefits of improving vascular function and lessening ischemia in women with microvascular angina, perfusion defect in cardiac MRI, and normal coronary arteries.

The UMPIRE trial is a multi-center, prospective, randomized, placebo controlled trial, designed to evaluate the effect of udenafil in improvement of myocardial stress perfusion defect in cardiac MRI, in women patients with microvascular angina. A total of 70 patients will be randomized to udenafil(100 mg q d) or placebo treatment. The primary end point of the study is Change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment. The secondary endpoints of this study are change of perfusion defect less than 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment, decrement of frequency of chest pain, improvement of ST-depression in stress test, improvement of duke score in stress test, improvement of QoL assessment by SF-36 questionnaire, improvement of sexual dysfunction assessment by BISF-W self-questionnaire and improvement of biomarkers foe endothelial function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. MVA patients with typical symptom and positive adenosine-stress cardiac MRI and with normal coronary artery in coronary angiogram or coronary artery CT angiography.

2. Definition of positive adenosine-stress MRI: perfusion defect > 25% of transmurality ( by 2 radiologist based on visual assessment and qualitative assessment in core-lab)

3. Gender: female

4. Age: 18-80

Exclusion Criteria:

1. The patient with contraindication to MR contrast media or MR 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 with suspected, pregnant women or women with lactation

14. QT prolongation syndrome or take drugs that prolong the QT interval - Antiarrhythmics class IA; quinidine, procainamide - Antiarrhythmics class III; amiodarone, sotalol

15. 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)

16. 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

17. Allergy or sensitivity with PDE 5 inhibitors

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chest Pain
• Microvascular Angina

Intervention

Drug:
• Udenafil
70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg po q d for 3 months.
• placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	to change of frequency of chest pain		baseline, 3 months after treatment	No
Other	to change of improvement of ST-depression in ECG		baseline, 3 months after treatment	No
Other	to change of QoL(Quality of Life)		baseline, 3 months after treatment	No
Other	to change of sexual dysfunction		baseline, 3 months after treatment	No
Other	to change of improvement of biomarkers for endothelial function		baseline and 3 months after treatment	No
Primary	to change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment.		baseline, 3 months after treatment	No
Secondary	to change of perfusion defect less than 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment		baseline, 3 months after treatment	No