HEART: Pilot Randomized Controlled Trial

Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Aortic Aneurysm
• Intervention / Treatment: Drug: Spironolactone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Saad Omar; Phone Number: 507-538-5162; Email: omar.saad@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Saad Omar; Phone Number: 507-538-5162
      • Principal Investigator: Thais D Coutinho

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. 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);
2. no antihypertensive use or stable antihypertensive regimen ≥ 4 weeks;
3. eGFR ≥ 50 mL/min/1.73 m²;
4. serum potassium ≤ 5.1 mmol/L;
5. ability to provide informed consent.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	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.
Experimental: Spironolactone	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Thais Coutinho, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: spironolactone; aortic aneurysm; arterial stiffness; aortic stiffness; thoracic aortic aneurysm
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Organic Chemicals; Polycyclic Compounds; Pregnanes; Steroids; Fused-Ring Compounds; Lactones; Pregnenes; Spironolactone
• Other Study ID Numbers: 25-014938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No