A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
VALUE
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
2 other identifiers
interventional
120
1 country
1
Brief Summary
The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2024
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2023
CompletedFirst Posted
Study publicly available on registry
November 29, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
August 3, 2025
July 1, 2025
4.2 years
November 21, 2023
July 30, 2025
Conditions
Outcome Measures
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).
Baseline; Week 52
Secondary Outcomes (1)
Change in Exercise Capacity (peak VO2)
Baseline; Week 52
Study Arms (3)
Losartan Group
EXPERIMENTALSubjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.
Amlodipine Group
ACTIVE COMPARATORSubjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.
Placebo Group
PLACEBO COMPARATORSubjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.
Interventions
Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.
Eligibility Criteria
You may qualify if:
- B/S1 hypertension
- SBP 100-139 average based on 3 office measurements.
- Age 18 or Older
- Previous COA Repair
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Egbe, MBBS, MPH
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2023
First Posted
November 29, 2023
Study Start
April 1, 2024
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
August 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share