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NCT07483177PHASE1, PHASE2Recruiting

HEART: Pilot Randomized Controlled Trial

Mayo Clinic

Start Date

5/25/2026

Completion Date

5/1/2028

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Spironolactone

DRUG

Placebo

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Conditions

Thoracic Aortic Aneurysm

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States