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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL162830-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan Group | Experimental | Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan. |
|
| Amlodipine Group | Active Comparator | Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine. |
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| Placebo Group | Placebo Comparator | Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | 50mg administered orally once daily for 52 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular (LV) Fibrosis | LV fibrosis will be measured via indexed Extracellular Volume (iECV) which will be calculated as extracellular volume fraction (ECV%) x LV End Diastolic Volume Index as evaluated during Cardiac Magnetic Resonance Imaging (CMRI). | Baseline; Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Capacity (peak VO2) | Change in Exercise Capacity will be evaluated based on peak VO2, measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min), during supine bike cardiopulmonary exercise test (Stress Echocardiogram). | Baseline; Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ACHD Research Program | Contact | (507) 293-2565 | RSTACHDRESPRG@mayo.edu | |
| Alexander Egbe, MBBS, MPH | Contact | (507) 284-2520 | Egbe.Alexander@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Egbe, MBBS, MPH | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D001017 | Aortic Coarctation |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Amlodipine | Drug | 5mg Amlodipine administered orally once daily for 52 weeks. |
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| Placebo | Drug | Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks. |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014652 | Vascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |