A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Losartan, Amlodipine, Placebo.
- Who it may be relevant to
- Registry conditions: Coarctation of Aorta, High Blood Pressure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.
Interventions
- Drug Losartan
50mg administered orally once daily for 52 weeks. - Drug Amlodipine
5mg Amlodipine administered orally once daily for 52 weeks. - Drug Placebo
Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.
Primary outcome measures
- Change in Left Ventricular (LV) Fibrosis [Time frame: Baseline; Week 52]
Secondary outcome measures (1)
- Change in Exercise Capacity (peak VO2) [Time frame: Baseline; Week 52]
Eligibility criteria
Inclusion criteria
- B/S1 hypertension
- SBP 100-139 average based on 3 office measurements.
- Age 18 or Older
- Previous COA Repair
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06150560 · 23-007629 · 1R01HL162830-01A1