HEART: Pilot RCT

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 01/14/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Thais Coutinho

Contact us for the latest status

Contact information:

Saad Omar

(507) 538-5162

omar.saad@mayo.edu

More information

Publications

Publications are currently not available