See if spironolactone can reduce aortic stiffness in adults with thoracic aortic aneurysm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized controlled trial compares spironolactone to placebo in adults with degenerative thoracic aortic aneurysm to see if the medication lowers aortic stiffness, measured by carotid-femoral pulse wave velocity. The trial includes adults 18 and older with aneurysm thresholds adjusted for age, sex, and body size, and requires stable or no antihypertensive therapy. Key safety criteria include adequate kidney function and potassium levels, with exclusions for certain heritable aortopathies, prior aortic surgery, and other conditions that could affect measurement. The study is conducted at Mayo Clinic in Rochester, and is led by Mayo Clinic with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Adults ≥ 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 (≥ 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 ≥ 4 weeks;
3. eGFR ≥ 50 mL/min/1.73 m²;
4. serum potassium ≤ 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.

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Thais Coutinho — Mayo Clinic
• Study coordinator: Saad Omar
• Email: omar.saad@mayo.edu
• Phone: 507-538-5162

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.