RecruitingPhase 1Phase 2NCT07483177

HEART: Pilot Randomized Controlled Trial

Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)

Sponsor

Mayo Clinic

Enrollment

50 participants

Start Date

May 25, 2026

Study Type

INTERVENTIONAL

Conditions

Thoracic Aortic Aneurysm

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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.

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Interventions

DRUGSpironolactone

Subjects will receive spironolactone 25 mg once daily for the first 4 weeks, followed by an increased dose of 50 mg once daily for an additional 5 months.

DRUGPlacebo

Subjects will receive 25 mg of the placebo once daily for the first 4 weeks, followed by an increased dose of 50 mg once daily for an additional 5 months.