HEART: Pilot Randomized Controlled Trial

NCT07483177 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 25-014938
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Aortic Aneurysm

Keywords

spironolactone; aortic aneurysm; thoracic aortic aneurysm; aortic stiffness; arterial stiffness

Outcome Measures

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

  Baseline, 6 months

Secondary Outcomes (4)

• Changes in central blood pressure

  Baseline, 6 months

• Aortic characteristic impedance

  Baseline, 6 months

• Total and proximal arterial compliance

  Baseline, 6 months

• Indices of wave reflection

  Baseline, 6 months

Study Arms (2)

Spironolactone

EXPERIMENTAL

Drug: Spironolactone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Spironolactone DRUG

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.

Spironolactone

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Aneurysm

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Thais Coutinho

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saad Omar

CONTACT

507-538-5162; omar.saad@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)