HEART: Pilot Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Spironolactone, Placebo.
- Who it may be relevant to
- Registry conditions: Thoracic Aortic Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)
Overview
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
- Drug Spironolactone
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. - Drug Placebo
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.
Primary outcome measures
- Change in Carotid-femoral pulse wave velocity (cfPWV) [Time frame: Baseline, 6 months]
Secondary outcome measures (4)
- Changes in central blood pressure [Time frame: Baseline, 6 months]
- Aortic characteristic impedance [Time frame: Baseline, 6 months]
- Total and proximal arterial compliance [Time frame: Baseline, 6 months]
- Indices of wave reflection [Time frame: Baseline, 6 months]
Eligibility criteria
Inclusion criteria
- 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;
- ability to provide informed consent.
Exclusion criteria
- 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;
- permanent atrial fibrillation/flutter;
- major peripheral artery disease affecting the carotids, iliacs and/or external femoral arteries precluding cfPWV measurement;
- current use of spironolactone, eplerenone or finererone;
- pregnancy or lactation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07483177 · 25-014938