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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06150560
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Losartan — DRUG
    50mg administered orally once daily for 52 weeks.
  • Amlodipine — DRUG
    5mg Amlodipine administered orally once daily for 52 weeks.
  • Placebo — DRUG
    Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.

Study Details

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

Key Dates

Start date
Apr 1, 2024
Status verified
Jul 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Losartan Group
    Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.
  • Active Comparator: Amlodipine Group
    Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.
  • Placebo Comparator: Placebo Group
    Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.

Primary Outcome Measure

Change in Left Ventricular (LV) Fibrosis [ Time Frame: Baseline; Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
ACHD Research Program
[email protected]
(507) 293-2565
Alexander Egbe, MBBS, MPH
[email protected]
(507) 284-2520
Alexander Egbe, MBBS, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Mayo Clinic in Rochester· Rochester, MN

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