Recruiting
Phase 3

Losartan

Sponsor:

Mayo Clinic

Code:

NCT06150560

Conditions

Coarctation of Aorta

High Blood Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Losartan

Amlodipine

Placebo

Study Details

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.

Conditions

Coarctation of Aorta

High Blood Pressure

Study ID

NCT06150560

Start date

Apr 1, 2024

Status verified date

Sep, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Losartan

50mg administered orally once daily for 52 weeks.

Amlodipine

5mg Amlodipine administered orally once daily for 52 weeks.

Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

ACHD Research Program

(507) 293-2565RSTACHDRESPRG@mayo.edu

Alexander Egbe, MBBS, MPH

(507) 284-2520Egbe.Alexander@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

ACHD Research Program

(507) 293-2565RSTACHDRESPRG@mayo.edu

Alexander Egbe, MBBS, MPH

(507) 284-2520Egbe.Alexander@mayo.edu

Principal Investigator:

Alexander Egbe, MBBS, MPH

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-11.