Actively Recruiting
Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)
Led by Mayo Clinic · Updated on 2026-06-08
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether spironolactone can reduce aortic stiffness in adults with degenerative thoracic aortic aneurysms. This study compares spironolactone to a placebo to see how it affects the stiffness of the aorta, measured by carotid-femoral pulse wave velocity (cfPWV). The trial is a pilot randomized controlled study led by Mayo Clinic and includes adults 18 years and older with specific aortic enlargement. Participants will be randomly assigned to receive either spironolactone or a placebo. The treatment starts with a dose of 25 mg once daily for the first 4 weeks, then increases to 50 mg once daily for an additional 5 months. The study uses triple masking to keep the treatment assignments hidden from participants and researchers. During the study, participants will have their aortic stiffness measured at the start and after 6 months through tests like cfPWV and assessments of blood pressure and arterial compliance. Researchers will track changes in central blood pressure, aortic impedance, and wave reflections. The total treatment period is 6 months, with safety and effectiveness monitored throughout the trial.
CONDITIONS
Brief Title
HEART: Pilot Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with degenerative thoracic aortic aneurysm of the aortic root and/or ascending aorta exceeding the normal size for age, sex, and body size
- No antihypertensive use or stable antihypertensive treatment for at least 4 weeks
- Estimated glomerular filtration rate (eGFR) of 50 mL/min/1.73 m² or higher
- Serum potassium level of 5.1 mmol/L or lower
- Ability to give informed consent
You will not qualify if you...
- Heritable aortopathies such as Marfan, Loeys-Dietz, vascular Ehlers-Danlos, Turner syndromes, familial or genetically proven thoracic aortic aneurysms
- Bicuspid aortic valve
- Inflammatory aortitis
- Prior aortic surgery, endovascular repair, or acute aortic syndrome
- Permanent atrial fibrillation or flutter
- Major peripheral artery disease affecting carotid, iliac, or external femoral arteries that prevents measurement of carotid-femoral pulse wave velocity
- Current use of spironolactone, eplerenone, or finerenone
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 months
Participants receive spironolactone or placebo daily, starting with 25 mg once daily for 4 weeks, followed by 50 mg once daily for an additional 5 months.
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
S
Saad Omar
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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