HEART: Pilot Randomized Controlled Trial
ConditionThoracic Aortic Aneurysm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Heritable aortopathies (Marfan, Loeys-Dietz, vascular Ehlers-Danlos, Turner syndromes; familial TAA, genetically-proven TAA);
bicuspid aortic valve;
inflammatory aortitis,
prior aortic surgery, endovascular repair, or acute aortic syndrome;
Trial design
Treatments tested in this trial
- Spironolactone
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov