Health TrialsbyHealthPanel

HEART: Pilot Randomized Controlled Trial

ConditionThoracic Aortic Aneurysm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: SpironolactoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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