Recruiting
Phase 1
Phase 2

Spironolactone

Sponsor:

Mayo Clinic

Code:

NCT07483177

Conditions

Thoracic Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spironolactone

Placebo

Study Details

Brief 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.

Conditions

Thoracic Aortic Aneurysm

Study ID

NCT07483177

Start date

May 25, 2026

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spironolactone

placebo comparator: Placebo

Interventions

Spironolactone

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.

Placebo

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.

Primary outcome measure

  • Change in Carotid-femoral pulse wave velocity (cfPWV) [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Saad Omar

507-538-5162

Principal Investigator:

Thais D Coutinho

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • spironolactone
  • aortic aneurysm
  • thoracic aortic aneurysm
  • aortic stiffness
  • arterial stiffness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-08.