Clinical trial of a novel treatment for peripheral arterial disease

Years funded:
2018 - 2019

Peripheral arterial disease (PAD) is a debilitating condition prevalent in people over 70. 

The symptoms involve leg pain after exercise and in severe cases pain at rest, ulcers and gangrene. 25% of people with severe disease need a leg amputation within a year. 

The current treatment options are limited and often ineffective. PAD occurs in patients with a build up of cholesterol in their blood vessels, with resulting poor blood flow to the lower limbs. 

Nitric oxide (NO), generated from the inner lining of blood vessels, is a key molecule in protecting arteries from PAD. NO is impaired in PAD and we have identified a protective pathway involving stimulation of a molecule called the beta 3 adrenergic receptor (ß3AR). 

By stimulating the ß3AR we have found that blood flow to the limbs is substantially improved in a pre-clinical model of PAD. We now aim to test the effect of a similar drug in humans. 

In this pilot clinical trial, we will test the effectiveness in PAD of Mirabegron, a ß3AR stimulator, that is safe and tolerated in humans for unrelated diseases. 

We hypothesise that patients receiving Mirabegron will show improvement in their exercise ability (peak walk time) over 3 months compared with placebo controls. 

This pilot study will inform the design of a larger, multi-centre study, and assist us in applying for the larger funding required. 

ß3AR stimulators may prove an improved and imminently translatable treatment for sufferers of PAD.

Researcher Profile

Dr Kristen Bubb

Institute: University of Sydney
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