ClinicalTrials.gg
RecruitingNCT07483177Updated Jun 8, 2026

HEART: Pilot Randomized Controlled Trial

A Phase 1/2 interventional study of Spironolactone and Placebo in Thoracic Aortic Aneurysm, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Thoracic Aortic Aneurysm

Keywords

  • spironolactone
  • aortic aneurysm
  • thoracic aortic aneurysm
  • aortic stiffness
  • arterial stiffness
03

In context

Aortic Aneurysm, Thoracic

131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 62 interventional studies indexed under Aortic Aneurysm, Thoracic.

Browse Aortic Aneurysm, Thoracic studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adults ≥ 18 years old with dTAA of the aortic root and/or ascending aorta exceeding the 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. ≥ 50 mL/min/1.73 m²;
  4. serum potassium ≤ 5.1 mmol/L;
  5. ability to provide .

Exclusion criteria

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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Spironolactone

    Drug: Spironolactone

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Changes in central blood pressure

    Central blood Pressure will be measured using a electronic sphygmomanometer and reported as mmHg

    Time frame: Baseline, 6 months

  2. 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

    Time frame: Baseline, 6 months

  3. Total and proximal arterial compliance

    Change in artery diameter (millimeter) assessed via ultrasound per change in artery pressure (mm Hg) assessed via tonometry.

    Time frame: Baseline, 6 months

  4. Indices of wave reflection

    Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index

    Time frame: Baseline, 6 months

07

Study locations

1 of 1 sites recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
    Recruiting
    • Saad Omar · Contact507-538-5162
    • Thais D Coutinho · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07483177
Lead sponsor
Mayo Clinic
Responsible party
Thais Coutinho (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Mar 19, 2026
Start date
May 25, 2026
Primary completion
May 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Jun 8, 2026

Study contacts

Saad Omar
Contact
omar.saad@mayo.edu
507-538-5162
Thais Coutinho
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Spironolactone

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