Coarctation of AortaPhase 3VALUENCT06150560
A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)
A Phase 3 study testing Losartan and Amlodipine in people with Coarctation of Aorta and High Blood Pressure, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coarctation of Aorta, High Blood Pressure
- What is being tested?
- Losartan and Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- B/S1 hypertension
- SBP 100-139 average based on 3 office measurements.
- Age 18 or Older
- Previous COA Repair
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
ACHD Research Program, (507) 293-2565, RSTACHDRESPRG@mayo.edu
Alexander Egbe, MBBS, MPH, (507) 284-2520, Egbe.Alexander@mayo.edu
About this study
Official title: 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.
- Conditions
- Coarctation of Aorta, High Blood Pressure
- Being tested
- Losartan, Amlodipine, Placebo
- Medical subject headings
- Aortic Coarctation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
50mg administered orally once daily for 52 weeks.
AmlodipineDrug
5mg Amlodipine administered orally once daily for 52 weeks.
PlaceboDrug
Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Losartan Group | Experimental | Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan. Receives: Drug: Losartan |
| Amlodipine Group | Active comparator | Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine. Receives: Drug: Amlodipine |
| Placebo Group | Placebo comparator | Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular (LV) Fibrosis
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).
Measured: Baseline; Week 52
Secondary outcomes (1)
Change in Exercise Capacity (peak VO2)
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).
Measured: Baseline; Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Apr 2024
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coarctation of AortaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alexander C. Egbe, Mayo Clinic
- Investigators
- Alexander Egbe, MBBS, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150560
- Sponsor's protocol ID
- 23-007629
- Other IDs
- 1R01HL162830-01A1
- Acronym
- VALUE
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06150560
- Acronym / sponsor ID
- VALUE / 23-007629
- Conditions
- Coarctation of Aorta, High Blood Pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Losartan Group | Experimental | Drug: LosartanSubjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan. |
| Amlodipine Group | Active comparator | Drug: AmlodipineSubjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine. |
| Placebo Group | Placebo comparator | Drug: PlaceboSubjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- B/S1 hypertension
- SBP 100-139 average based on 3 office measurements.
- Age 18 or Older
- Previous COA Repair
Key exclusion criteria (7 listed)
- Currently on beta blocker (BB) therapy
- Pregnancy/lactating
- eGFR<30
- Hyperkalemia (serum potassium >5.5mmol/L)
- Severe Aortic or Mitral valve stenosis or regurgitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanAlso: Cozaar50mg administered orally once daily for 52 weeks. | Drug | Losartan Group |
| Amlodipine5mg Amlodipine administered orally once daily for 52 weeks. | Drug | Amlodipine Group |
| PlaceboOral capsules that contain no active drug ingredients administered orally once daily for 52 weeks. | Drug | Placebo Group |
Primary outcome
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).
1 secondary outcome
Change in Exercise Capacity (peak VO2)
Time frame: Baseline; Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Coarctation of Aorta
Enrolling by invitation
Effects of Exercise in Patients With Repaired Coarctation of the Aorta
Coarctation of the Aorta, Coarctation of Aorta
Enrolling by invitationObservational study
The Arch Watch Study: An Integrated Evaluation of Hemodynamics in Infants With Suspected Coarctation of the Aorta
Coarctation of the Aorta, Aortic Arch Obstruction
RecruitingObservational study
Valvular Aortic Stenosis Prognosis Study
Morality
Not yet recruiting
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
Aortic Coarctation, Pulmonary Artery Stenosis
Not yet recruitingObservational study
Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery
Aortic Coarctation, Cardiac Output, Low
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Egbe, MBBS, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Losartan and Amlodipine in people with Coarctation of Aorta and High Blood Pressure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ACHD Research Program ((507) 293-2565, RSTACHDRESPRG@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular (LV) Fibrosis (time frame: Baseline; Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.