HEART: Pilot Randomized Controlled Trial

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07483177
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Thoracic Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 25, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Spironolactone
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in Carotid-femoral pulse wave velocity (cfPWV) [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Saad Omar
507-538-5162
Thais D Coutinho (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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