Thoracic Aortic AneurysmPhase 1/2NCT07483177
HEART: Pilot Randomized Controlled Trial
A Phase 1/2 study testing Spironolactone in people with Thoracic Aortic Aneurysm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Aortic Aneurysm
- What is being tested?
- Spironolactone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2026to May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Saad Omar, 507-538-5162
Thais D Coutinho
About this study
Official title: 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.
- Conditions
- Thoracic Aortic Aneurysm
- Being tested
- Spironolactone, Placebo
- Keywords
- spironolactone, aortic aneurysm, thoracic aortic aneurysm, aortic stiffness, arterial stiffness
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Spironolactone | Experimental | Not described Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 6 months
Secondary outcomes (4)
Changes in central blood pressure
Central blood Pressure will be measured using a electronic sphygmomanometer and reported as mmHg
Measured: 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
Measured: 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.
Measured: Baseline, 6 months
Indices of wave reflection
Aortic Wave Reflection will be measured via arterial tonometry, reported as aortic augmentation index
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start25 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thais Coutinho, Mayo Clinic
- Investigators
- Thais Coutinho, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483177
- Sponsor's protocol ID
- 25-014938
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects Of Aldosterone Receptor Blockade In Degenerative Thoracic Aortic Aneurysm: A Pilot Randomized Controlled Trial (HEART: Pilot RCT)
- ClinicalTrials.gov ID
- NCT07483177
- Acronym / sponsor ID
- 25-014938
- Conditions
- Thoracic Aortic Aneurysm
- Keywords
- spironolactone, aortic aneurysm, thoracic aortic aneurysm, aortic stiffness, arterial stiffness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolactone | Experimental | Drug: Spironolactone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneSubjects 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. | Drug | Spironolactone |
| PlaceboSubjects 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. | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
Changes in central blood pressure
Time frame: Baseline, 6 months
Aortic characteristic impedance
Time frame: Baseline, 6 months
Total and proximal arterial compliance
Time frame: Baseline, 6 months
Indices of wave reflection
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thais Coutinho principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Spironolactone in people with Thoracic Aortic Aneurysm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saad Omar (507-538-5162, omar.saad@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Carotid-femoral pulse wave velocity (cfPWV) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.