Hypertension Clinical Trial
To determine the effects of an angiotensin converting enzyme inhibitor (ACE inhibitor), fosinopril, on multiple blood markers in 286 adults at high risk for cardiovascular disease.
BACKGROUND:
Angiotensin converting enzyme inhibitors (ACE inhibitors) may prevent cardiovascular events
in high risk persons and improve skeletal muscle function in heart failure patients by means
of mechanisms that are independent of blood pressure changes. However, there is limited
knowledge of all the mechanisms underlying the therapeutic benefits of ACE inhibition. ACE
inhibitors may favorably modify markers of fibrinolysis, inflammation, endothelial function,
and extracellular tissue remodeling, all of which are associated with atherosclerosis and
cardiovascular disease. But, clinical trial evidence on these effects is limited. In
addition, polymorphisms of the ACE, angiotensinogen, PAI-1 and IL-6 genes may modify the
therapeutic response to ACE inhibitors.
DESIGN NARRATIVE:
This was a double-blind cross-over, randomized, placebo controlled trial in 286 persons with
high cardiovascular risk to compare the effects of 6 months of treatment with fosinopril and
6 months with placebo on the following primary outcomes: plasma plasminogen activator
inhibitor-1 (PAI-1) antigen, C- reactive protein (CRP), interleukin-6 (IL-6) and soluble
vascular cell adhesion molecule-1 (sVCAM-1). The secondary objectives were (a) to assess the
effects of fosinopril on IL-6/IL-6 Soluble Receptor ratio, PAI-1 activity, tissue
plasminogen activator (TPA) antigen, fibrinogen, endothelin-1, TNF-alpha, soluble
intercellular cell adhesion molecule-1 (sICAM-1), E-selectin, matrix metalloproteinase-1
(MMP-1) and tissue inhibitor of metalloproteinase-1 (TIMP-1); and (b) to explore the effects
of ACE, angiotensinogen, PAI-1, and IL-6 gene polymorphisms on these biomarkers, and test
the interaction of the gene polymorphisms with the effects of fosinopril. The study had
sufficient power to detect small changes in several biomarkers compared to placebo. The
assessment of these biological mechanisms had clinical relevance for identifying the
patients who may benefit the most from ACE inhibition. While the focus of the study was on
novel cardiovascular risk factors, the results may also have future implications for
developing new indications for ACE inhibitors, such as, for example, the prevention of
age-related muscle wasting and physical disabilities in older persons, for which
inflammation may be a causal factor.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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