A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
NCT ID: NCT06150560
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2024-04-01
2028-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Losartan Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.
Losartan
50mg administered orally once daily for 52 weeks.
Amlodipine Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.
Amlodipine
5mg Amlodipine administered orally once daily for 52 weeks.
Placebo Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.
Placebo
Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.
Interventions
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Losartan
50mg administered orally once daily for 52 weeks.
Amlodipine
5mg Amlodipine administered orally once daily for 52 weeks.
Placebo
Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* SBP 100-139 average based on 3 office measurements.
* Age 18 or Older
* Previous COA Repair
Exclusion Criteria
* Pregnancy/lactating
* eGFR\<30
* Hyperkalemia (serum potassium \>5.5mmol/L)
* Severe Aortic or Mitral valve stenosis or regurgitation
* Epicardial CAD diagnosis
* Received antihypertensive medications within the past year
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Alexander C. Egbe
Principal Investigator
Principal Investigators
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Alexander Egbe, MBBS, MPH
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-007629
Identifier Type: -
Identifier Source: org_study_id
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