Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Saad Omar
omar.saad@mayo.edu
507-538-5162
Time Frame
Start Date: 2026-05-25
Estimated Completion Date: 2028-05
Participants
Target number of participants: 50
Treatments
Experimental: Spironolactone
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic