Carnosine for Peripheral Vascular Disease

Summary

The investigators hypothesise that a home-based standardised exercise intervention with 2g of carnosine daily for 6 months will improve walking endurance in 104 patients with PVD aged 40-80 years compared to placebo and exercise through stabilisation of HIF1-α in the ischaemic leg. Aims Aim 1: Determine whether in patients with PVD, carnosine in addition to exercise improves: 1. walking endurance (6-min walk test; primary outcome); 2. initial claudication distance (ICD), and absolute claudication distance (ACD; treadmill), cadence, resting and exercise ABI; and 3. central blood pressure, endothelial function, arterial (aortic) stiffness, lipid profile; and 4. quality of life as determined by EuroQol-5D (all secondary outcomes). 5. Improve cognitive function (global cognitive score formed by a composite of 7 cognitive tests) Aim 2: Delineate the mechanisms by which carnosine improves walking endurance: 1. protein expression of pro-angiogenic and carnosine related genes, including carnosine transporters in the skeletal muscle biopsies, EPCs in peripheral blood and quantitative proteomic studies. 2. other mechanisms demonstrated in animal studies including plasma inflammatory markers, serum and urinary advanced glycation (AGE) and lipoxidation (ALE) end-products (tertiary outcomes). This trial will provide evidence for use of carnosine as a therapeutic intervention for PVD patients and, if positive, will have immediate clinical application.

Timeline

Start

2019-03-01

Primary completion

2022-12-31

Completion

2022-12-31

Drugs

Indications