Not Yet RecruitingPhase 1/2

HEART: Pilot Randomized Controlled Trial

United States50 participantsStarted 2026-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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);
✓. no antihypertensive use or stable antihypertensive regimen ≥ 4 weeks;
✓. eGFR ≥ 50 mL/min/1.73 m²;
✓. serum potassium ≤ 5.1 mmol/L;
✓. ability to provide informed consent.

Exclusion criteria

✕. Heritable aortopathies (Marfan, Loeys-Dietz, vascular Ehlers-Danlos, Turner syndromes; familial TAA, genetically-proven TAA);
✕. bicuspid aortic valve;
✕. inflammatory aortitis,
✕. prior aortic surgery, endovascular repair, or acute aortic syndrome;
✕. permanent atrial fibrillation/flutter;
✕. major peripheral artery disease affecting the carotids, iliacs and/or external femoral arteries precluding cfPWV measurement;
✕. current use of spironolactone, eplerenone or finererone;
✕. pregnancy or lactation.

What they're measuring

Change in Carotid-femoral pulse wave velocity (cfPWV)

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT07483177

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Saad Omar

507-538-5162 omar.saad@mayo.edu

View on ClinicalTrials.gov More Thoracic Aortic Aneurysm trials