Peripheral Arterial Disease Clinical Trial
Official title:
Use of Entresto (Sacubitril/Valsartan) for the Treatment of Peripheral Arterial Disease
This study proposes the use of Entresto (sacubitril/valsartan) to test the effects on pain free walking duration on patients with peripheral arterial disease, a condition caused by decreased blood flow to the muscles in the legs.
Current approaches for the treatment of peripheral arterial disease (PAD) lack the success
observed in the treatment of other forms of vascular diseases. A potential reason for this
may be that available treatments do not target the pathological mechanisms implicated in the
development of PAD. These mechanisms include obstruction of aortic-iliac arteries and its
branches due to the formation of atherosclerotic plaques and mitochondrial and microvascular
dysfunction. Although blood flow improves following surgical revascularization, pain free and
maximal walking duration does not improve to the same degree. This suggests that in addition
to blood flow obstruction, mitochondrial and microvascular dysfunction are significant
factors implicated in the development of PAD.
Therefore, any treatment designed for patients with PAD should be aimed at improving
mitochondrial and microvascular function. In this regard, natriuretic peptides (NP) have been
shown to increase mitochondrial and microvascular density and these two findings have been
associated with increases in oxygen consumption and perfusion of skeletal muscles.
The Investigator proposes that an increase in endogenous natriuretic peptides by inhibiting
the enzyme that degrades it in blood will increase mitochondrial and microvascular function
and this will be associated with an increase in maximal and pain free walking duration. To
test this hypothesis the investigators have designed a double blind randomized controlled
clinical trial providing sacubitril/valsartan for 12 weeks trial period.The improvements in
mitochondrial and microvascular function will be measured using magnetic resonance (MR)
spectroscopy and functional MR imaging and an exercise stress test will be used to assess
maximal and pain free walking duration. This trial will provide patients with PAD with a
non-surgical, cause-specific treatment option.
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