HEART: Pilot Randomized Controlled Trial

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

  • Thoracic Aortic Aneurysm

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