Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)
Mayo Clinic
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
- Age range
- 18+ years
- Sex
- All
- 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, T…
Interventions
- DrugSpironolactone
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.
- DrugPlacebo
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.
Location
- Mayo Clinic in RochesterRochester, Minnesota