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โ† Trials
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HEART: Pilot Randomized Controlled Trial

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllMayo Clinic
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to determine whether spironolactone reduces aortic stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), compared with placebo, in patients with degenerative thoracic aortic aneurysms.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria 1. Adults โ‰ฅ 18 years old with dTAA of the aortic root and/or ascending aorta exceeding the upper limit of normal for age, sex, and body surface area (โ‰ฅ 4.0 cm as an example of a common threshold; but age, sex and body size-specific thresholds have been established for the aortic root24 and ascending aorta25); 2. no antihypertensive use or stable antihypertensive regimen โ‰ฅ 4 weeks; 3. eGFR โ‰ฅ 50 mL/min/1.73 mยฒ; 4. serum potassium โ‰ค 5.1 mmol/L; 5. ability to provide informed consent. Exclusion Criteria 1. Heritable aortopathies (Marfan, Loeys-Dietz, vascular Ehlers-Danlos, Turner syndromes; familial TAA, genetically-proven TAA); 2. bicuspid aortic valve; 3. inflammatory aortitis, 4. prior aortic surgery, endovascular repair, or acute aortic syndrome; 5. permanent atrial fibrillation/flutter; 6. major peripheral artery disease affecting the carotids, iliacs and/or external femoral arteries precluding cfPWV measurement; 7. current use of spironolactone, eplerenone or finererone; 8. pregnancy or lactation.
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What it tests

  • Spironolactone
  • Placebo
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Where

1 site
Mayo Clinic in Rochester
Rochester, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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