Evaluating Losartan for treating coarctation of the aorta and high blood pressure
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
PHASE3 · Mayo Clinic · NCT06150560
This study is testing if the medication Losartan can help people who have high blood pressure and a heart condition called coarctation of the aorta feel better compared to another medication or a placebo.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06150560 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness and underlying mechanisms of Losartan, an angiotensin-II receptor blocker, in patients with coarctation of the aorta and hypertension. Participants will receive either Losartan, Amlodipine, or a placebo to determine the best treatment approach. The study focuses on individuals who have previously undergone repair for coarctation of the aorta and have specific blood pressure measurements. The goal is to improve cardiovascular remodeling and overall patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with a history of coarctation of the aorta repair and specific blood pressure criteria.
Not a fit: Patients currently on beta blocker therapy, pregnant or lactating, or with severe cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with coarctation of the aorta and hypertension.
How similar studies have performed: Previous studies have shown promise in using angiotensin-II receptor blockers for hypertension, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Alexander Egbe, MBBS, MPH — Mayo Clinic
- Study coordinator: ACHD Research Program
- Email: RSTACHDRESPRG@mayo.edu
- Phone: (507) 293-2565
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coarctation of Aorta, High Blood Pressure