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Spironolactone for Aortic Aneurysm

SO
Overseen BySaad Omar

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether spironolactone can reduce the stiffness of the aorta, a major blood vessel, in individuals with degenerative thoracic aortic aneurysms. The researchers aim to determine if spironolactone, a medication often used for heart-related issues, is more effective than a placebo (a harmless pill with no active drug) in managing this condition. It suits adults with a thoracic aortic aneurysm larger than usual who are not currently changing their blood pressure medication. As a Phase 1, Phase 2 trial, this research focuses on understanding how spironolactone works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage medical advancements.

Do I need to stop my current medications for the trial?

If you are on a stable antihypertensive medication regimen for at least 4 weeks, you can continue taking it. However, if you are currently using spironolactone, eplerenone, or finererone, you cannot participate in the trial.

Is there any evidence suggesting that spironolactone is likely to be safe for humans?

Research has shown that spironolactone is safely used in various medical treatments. Studies have found it can reduce stiffness in the aorta (a major blood vessel) without causing major side effects. For instance, one study noted a significant decrease in the risk of death from any cause with spironolactone use, indicating it is generally well-tolerated. Another study examined real-world side effects and confirmed its good safety record, meaning it didn't cause many serious side effects in everyday use. While spironolactone undergoes testing for new purposes, these findings reassure those considering joining a trial about its safety.12345

Why do researchers think this study treatment might be promising for aortic aneurysm?

Unlike the standard treatments for aortic aneurysm, which typically involve surgical interventions or blood pressure medications like beta-blockers, spironolactone offers a novel approach. Spironolactone is a mineralocorticoid receptor antagonist that could potentially reduce the stress on the aortic wall by controlling aldosterone, a hormone that can contribute to vascular damage. Researchers are excited about spironolactone because it targets the hormonal pathways involved in aneurysm progression, potentially offering a less invasive and more targeted option compared to current treatment methods.

What evidence suggests that spironolactone might be an effective treatment for aortic aneurysm?

Research has shown that spironolactone might help treat aortic aneurysms by reducing inflammation and slowing their growth. Studies found that spironolactone decreased the size of the aorta, suggesting its potential effectiveness in managing aneurysms. It also improved aortic flexibility in patients with resistant high blood pressure, which could benefit aortic conditions like aneurysms. Although these results are promising, further research is necessary to confirm its effectiveness specifically for aortic aneurysms. Participants in this trial will receive either spironolactone or a placebo to further evaluate its potential benefits.12567

Who Is on the Research Team?

TC

Thais Coutinho

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults (18+) with a degenerative thoracic aortic aneurysm in the root or ascending part of the aorta that is larger than normal for their age, sex, and body size. Participants must have stable or no blood pressure meds, good kidney function, safe potassium levels, and be able to give consent.

Inclusion Criteria

I do not take blood pressure medicine or my dose has not changed for 4 weeks.
3. eGFR ≥ 50 mL/min/1.73 m²;
4. serum potassium ≤ 5.1 mmol/L;
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spironolactone or placebo to assess its effect on aortic stiffness

6 months
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Spironolactone

Trial Overview

The study compares spironolactone—a medication often used for heart conditions—to a placebo to see if it can reduce stiffness in the main artery (aorta) among people with thoracic aortic aneurysms. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: SpironolactoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Pharmacologic inhibition by spironolactone attenuates ... - PMC

Spironolactone can mitigate aortic inflammation and remodeling to attenuate AAA formation as well as decrease growth of pre-formed aneurysms.

Efficacy of spironolactone in reducing the risk of ...

In the Legacy cohort, spironolactone users had a significantly lower risk of all-cause mortality (HR 0.92 (95% CI, 0.86-0.99, p=0.03) but with ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36776267/

Pharmacologic inhibition by spironolactone attenuates ...

Results: In the elastase AAA model, spironolactone treatment displayed a significant decrease in aortic diameter compared to elastase-treated ...

Spironolactone for Aortic Aneurysm · Info for Participants

The purpose of this study is to determine whether spironolactone reduces aortic stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), ...

Long-term Use of Antihypertensive Medications and ...

Compared with other antihypertension agents, β-blockers and ACEIs or ARBs may be associated with benefits in the long-term treatment of aortic dissection.

Safety evaluation and cardiovascular effect of additional ...

Treatment with spironolactone was associated with a significant reduction in all-cause mortality [OR=0.4, 95%CI (0.24, 0.66), P=0.0003] (Figure ...

Pharmacologic inhibition by spironolactone attenuates ...

It is demonstrated that spironolactone can mitigate aortic inflammation and remodeling to attenuate AAA formation as well as decrease growth of pre-formed ...