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Angiotensin-II Receptor Blocker

Losartan for Coarctation of the Aorta (VALUE Trial)

Phase 3

Recruiting

Led By Alexander Egbe, MBBS, MPH

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

B/S1 hypertension; SBP 120-139 average based on 3 office measurements.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; week 52

Awards & highlights

VALUE Trial Summary

This trial investigates if a drug called Losartan can help treat a condition called coarctation of aorta.

Who is the study for?

This trial is for adults with a history of early childhood repair of coarctation of the aorta and slightly elevated blood pressure. They must not be on beta blockers, pregnant, or have severe kidney issues, high potassium levels, significant heart valve problems, coronary artery disease, or taken blood pressure meds in the last year.Check my eligibility

What is being tested?

The study is testing Losartan's effectiveness against cardiovascular remodeling in patients who've had an aortic coarctation repair. It compares Losartan to Amlodipine and placebo to see which better improves heart structure and function.See study design

What are the potential side effects?

Losartan may cause dizziness due to low blood pressure, mild swelling from fluid retention, fatigue or weakness. Rarely it can increase potassium too much or affect kidney function.

VALUE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My average blood pressure is between 120-139.

VALUE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Left Ventricular (LV) Fibrosis

Secondary outcome measures

Change in Exercise Capacity (peak VO2)

Side effects data

From 2021 Phase 4 trial • 227 Patients • NCT02188121

43%

Laboratory values outside normal range

23%

Psychiatric Hospitalization

Medical Hospitalization

Elevated creatine kinase level

Muscle pain

Hypotension

Dehydration

Leukemia

Placed on Lithium while on Losartan

100%

80%

60%

40%

20%

Study treatment Arm

Statin and/or Angiotensin Receptor Blocker

Usual Treatment

VALUE Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Losartan GroupExperimental Treatment1 Intervention

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

Group II: Amlodipine GroupActive Control1 Intervention

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

Group III: Placebo GroupPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losartan

2003

Completed Phase 4

~3000

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,215 Previous Clinical Trials

3,767,123 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,004 Total Patients Enrolled

1 Trials studying Coarctation of the Aorta

Alexander Egbe, MBBS, MPHPrincipal InvestigatorMayo Clinic

3 Previous Clinical Trials

345 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation currently seeking participants?

"The clinicaltrials.gov website reveals that this study, which was first posted on December 1st 2023 and most recently updated on November 21st 2023 is not actively seeking participants at the moment. However there are currently 784 other trials searching for volunteers."

Answered by AI

Is usage of Losartan Group associated with any adverse health effects?

"There is existing evidence to support the safety of Losartan Group, thus it was assigned an evaluation score of 3. This phase 3 trial has produced a body of data that validate its efficacy and affirm its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Alexander C. Egbe 2024. "A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06150560.

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