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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
Must not have
Received antihypertensive medications within the past year
Currently on beta blocker (BB) therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 52
Awards & highlights
Pivotal 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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My average blood pressure is between 120-139.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have taken medication for high blood pressure in the last year.
Select...
I am currently taking beta blocker medication.
Select...
I have severe heart valve issues.
Select...
I have been diagnosed with coronary artery disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Left Ventricular (LV) Fibrosis
Secondary study objectives
Change in Exercise Capacity (peak VO2)
Side effects data
From 2021 Phase 4 trial • 227 Patients • NCT0218812143%
Laboratory values outside normal range
23%
Psychiatric Hospitalization
6%
Medical Hospitalization
2%
Elevated creatine kinase level
1%
Muscle pain
1%
Hypotension
1%
Dehydration
1%
Leukemia
1%
Placed on Lithium while on Losartan
100%
80%
60%
40%
20%
0%
Study treatment Arm
Statin and/or Angiotensin Receptor Blocker
Usual Treatment
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,821 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,823 Total Patients Enrolled
Alexander Egbe, MBBS, MPHPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
445 Total Patients Enrolled