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Number of candidates for this study is expected to be too small.
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The purpose of this study is to determine whether Sildenafil is effective in the treatment of sustained pulmonary artery hypertension after corrected mitral valve disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil | Experimental | Sildenafil 20mg tid for six months (* consider open-label extension study for 1 year) |
|
| Placebo | Placebo Comparator | Placebo tablets do not contain an active ingredient but are identical in shape with each active tablet of Sildenafil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Six Minutes Walk Distance | unit of measure : meter (m) | baseline and six months |
| Measure | Description | Time Frame |
|---|---|---|
| Borg dyspnea score | six months | |
| Exercise capacity by cardiopulmonary exercise test | six months | |
| Fractional area change of right ventricle measured by echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong-Min Song | Asan Medical Center | Principal Investigator |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
|
unit of measure : percent (%) |
| six months |
| Pulmonary vascular resistance (PVR) measured by cardiac catheterization | unit of measure : wood unit (WU) | six months |
| Systolic pulmonary artery pressure measured by cardiac catheterization | unit of measure : pressure (mmHg) | six months |
| Mean pulmonary artery pressure measured by cardiac catheterization | unit of measure : pressure (mmHg) | six months |
| D002318 |
| Cardiovascular Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |