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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Spironolactone
  • Drug: 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 Comparator
Placebo
  • Drug: 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.

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Saad Omar
507-538-5162

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.