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

Mayo Clinic

Status and phase: Enrolling; Phase 3

Conditions: High Blood Pressure; Coarctation of Aorta

Treatments: Drug: Amlodipine; Drug: Losartan; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06150560

23-007629

1R01HL162830-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 3 patient groups, including a placebo group

Losartan Group

Experimental group

Description:

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

Treatment:

Drug: Losartan

Amlodipine Group

Active Comparator group

Description:

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

Treatment:

Drug: Amlodipine

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo