RecruitingPhase 3NCT06150560

A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)

A Phase III, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating the Benefits and Mechanism Of Action Of Angiotensin-II Receptor Blocker On Cardiovascular Remodeling In Patients With Repaired Coarctation Of Aorta


Sponsor

Mayo Clinic

Enrollment

120 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • B/S1 hypertension
  • SBP 100-139 average based on 3 office measurements.
  • Age 18 or Older
  • Previous COA Repair

Exclusion Criteria7

  • Currently on beta blocker (BB) therapy
  • 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

Interventions

DRUGLosartan

50mg administered orally once daily for 52 weeks.

DRUGAmlodipine

5mg Amlodipine administered orally once daily for 52 weeks.

DRUGPlacebo

Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06150560


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