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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Carotid-femoral pulse wave velocity (cfPWV) | Carotid-femoral pulse wave velocity will be calculated by (Distance/Pulse Transit Time) and reported as m/s | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in central blood pressure | Central blood Pressure will be measured using a electronic sphygmomanometer and reported as mmHg | Baseline, 6 months |
| Aortic characteristic impedance | Aortic characteristic impedance will be reported as a ratio of increase in central pressure to the corresponding increase in aortic flow in early systole |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saad Omar | Contact | 507-538-5162 | omar.saad@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Thais Coutinho | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo | Drug | 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. |
|
| Baseline, 6 months |
| Total and proximal arterial compliance | Change in artery diameter (millimeter) assessed via ultrasound per change in artery pressure (mm Hg) assessed via tonometry. | Baseline, 6 months |
| Indices of wave reflection | Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index | Baseline, 6 months |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |