Thoracic Aortic Aneurysm
Conditions
Keywords
spironolactone, aortic aneurysm, thoracic aortic aneurysm, aortic stiffness, arterial stiffness
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.
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Carotid-femoral pulse wave velocity (cfPWV) | Baseline, 6 months | Carotid-femoral pulse wave velocity will be calculated by (Distance/Pulse Transit Time) and reported as m/s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in central blood pressure | Baseline, 6 months | Central blood Pressure will be measured using a electronic sphygmomanometer and reported as mmHg |
| Aortic characteristic impedance | Baseline, 6 months | Aortic characteristic impedance will be reported as a ratio of increase in central pressure to the corresponding increase in aortic flow in early systole |
| Total and proximal arterial compliance | Baseline, 6 months | Change in artery diameter (millimeter) assessed via ultrasound per change in artery pressure (mm Hg) assessed via tonometry. |
| Indices of wave reflection | Baseline, 6 months | Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index |
Countries
United States
Contacts
CONTACTSaad Omar
PRINCIPAL_INVESTIGATORThais Coutinho
Mayo Clinic
Outcome results
None listed