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

Primary Purpose

Microvascular Angina

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Udenafil

placebo

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

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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
-

Sites / Locations

Seoul National University Bundang HospitalRecruiting
Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Udenafil

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

to change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment.

Secondary Outcome Measures

to change of perfusion defect less than 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment

Full Information

NCT ID

NCT01769482

First Posted

November 20, 2012

Last Updated

March 24, 2014

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01769482

Brief Title

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

Acronym

UMPIRE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Microvascular Angina

Keywords

microvascular angina, PDE-5 inhibitors, Heart disease, Ischemia, Cardiac MRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Udenafil

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Udenafil

Other Intervention Name(s)

Zydena

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

to change of perfusion defect over 25% of baseline defect in adenosine-stress cardiac MRI after 3-month treatment.

Time Frame