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

NCT ID: NCT06150560

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2028-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coarctation of Aorta High Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Losartan Group

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

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

50mg administered orally once daily for 52 weeks.

Amlodipine Group

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

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

5mg Amlodipine administered orally once daily for 52 weeks.

Placebo Group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Losartan

50mg administered orally once daily for 52 weeks.

Intervention Type DRUG

Amlodipine

5mg Amlodipine administered orally once daily for 52 weeks.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cozaar

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Alexander C. Egbe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander Egbe, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ACHD Research Program

Role: CONTACT

(507) 293-2565

Alexander Egbe, MBBS, MPH

Role: CONTACT

(507) 284-2520

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ACHD Research Program

Role: primary

(507) 293-2565

Alexander Egbe, MBBS, MPH

Role: backup

(507) 284-2520

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01HL162830-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-007629

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.