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NCT Number: NCT07483177

HEART: Pilot Randomized Controlled Trial

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Saad Omar

CONTACT

507-538-5162

Thais D Coutinho

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Carotid-femoral pulse wave velocity (cfPWV)

    Time frame: Baseline, 6 months

    Carotid-femoral pulse wave velocity will be calculated by (Distance/Pulse Transit Time) and reported as m/s

Secondary outcomes

  1. Changes in central blood pressure

    Time frame: Baseline, 6 months

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

  2. Aortic characteristic impedance

    Time frame: Baseline, 6 months

    Aortic characteristic impedance will be reported as a ratio of increase in central pressure to the corresponding increase in aortic flow in early systole

  3. Total and proximal arterial compliance

    Time frame: Baseline, 6 months

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

  4. Indices of wave reflection

    Time frame: Baseline, 6 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Saad Omar

CONTACT

[email protected]

507-538-5162

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 19, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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