ClinicalTrials.gg
RecruitingNCT06150560VALUEUpdated Sep 11, 2026

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

A Phase 3 interventional study of Losartan and Amlodipine in Coarctation of Aorta and High Blood Pressure, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Mayo Clinic · Phase 3, Interventional, and Supportive care

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Coarctation of Aorta
  • High Blood Pressure
03

In context

Aortic Coarctation

49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.

This study's planned enrollment of 120 is above the median of 45 across 19 interventional studies indexed under Aortic Coarctation.

Browse Aortic Coarctation studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Currently on beta blocker (BB) therapy
  • Pregnancy/lactating
  • \<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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Losartan Group

    Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.

    Drug: Losartan

  • Active comparator
    Amlodipine Group

    Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.

    Drug: Amlodipine

  • Placebo comparator
    Placebo Group

    Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.

    Drug: Placebo

Interventions

  • 50mg administered orally once daily for 52 weeks.

    Also known as: Cozaar

  • 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline; Week 52

Secondary outcomes

  1. 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).

    Time frame: Baseline; Week 52

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06150560
Lead sponsor
Mayo Clinic
Responsible party
Alexander C. Egbe (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Nov 29, 2023
Start date
Apr 1, 2024
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

ACHD Research Program
Contact
RSTACHDRESPRG@mayo.edu
(507) 293-2565
Alexander Egbe, MBBS, MPH
Contact
Egbe.Alexander@mayo.edu
(507) 284-2520
Alexander Egbe, MBBS, MPH
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Losartan

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