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

March 28, 2024 updated by: Alexander C. Egbe, Mayo Clinic

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Alexander Egbe, MBBS, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • B/S1 hypertension; SBP 120-139 average based on 3 office measurements.
  • COA Repair prior to age 10
  • No residual COA; Based on mean doppler COA gradient <20mmHg within past 12 months

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Losartan Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.
Drug: Losartan
50mg administered orally once daily for 52 weeks.
Other Names:
  • Cozaar
Active Comparator: Amlodipine Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.
Drug: Amlodipine
5mg Amlodipine administered orally once daily for 52 weeks.
Placebo Comparator: Placebo Group
Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.
Drug: Placebo
Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular (LV) Fibrosis
Time Frame: Baseline; Week 52
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Exercise Capacity (peak VO2)
Time Frame: Baseline; Week 52
Change in Exercise Capacity will be evaluated based on peak VO2, measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min), during supine bike cardiopulmonary exercise test (Stress Echocardiogram).
Baseline; Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Alexander Egbe, MBBS, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-007629
  • 1R01HL162830-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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