Aneurysm Clinical Trial
Official title:
Captopril Versus Atenolol to Prevent Expansion Rate of Thoracic Aortic Aneurysms
Thoracic aortic aneurysms (TAA) are considered "silent killers" because they scarcely display
any symptomatology, but are correlated with significant mortality and morbidity. Current
guidelines regard aortic aneurysm disease as a coronary artery disease equivalent and suggest
aspirin and statin use to reduce the progression of atherosclerosis, as well as beta-blocker
(BB) therapy. No therapy, however, is effective at limiting aneurysm expansion and preventing
rupture, even in large trials. TAA has emerged as an inflammation-mediated disorder.
Angiotensin-converting enzyme inhibitors (ACEIs) can reduce the wall shear stress and
inflammation, both of which play vital roles in the expansion of the aneurysm.
The study will be a randomized, double-blind trial. Patients will be randomized into one of
two parallel arms, receiving captopril or atenolol. The doses of captopril and atenolol will
be 25 mg daily for the first 15 days, rising to 100 mg according to clinical tolerance and BP
estimates. The sample size will be set at 424 subjects (212 per group). The primary end-point
will be the rate of change in the absolute diameter of the aortic root and ascending aorta on
MRI of the aorta after 36 months of therapy with captopril vs. atenolol.
BBs have not been precisely found to decrease aneurysm growth rates. ACEIs could lead to the
prevention of aneurysm degeneration through their antihypertensive and anti-inflammatory
properties.
The results of this trial will clarify that ACEIs are superior to BB therapy in reducing the
growth rate of TAAs, the rate of change in aortic insufficiency, the time to aortic rupture
or dissection, the need for aortic surgery or intervention, and death.
n/a
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