A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Older People with Impaired Physical Function. - Allopurinol in Functional Impairment (ALFIE) Trial

niversity of Dundee, Tayside Clinical Trials Unit0 个研究点目标入组 124 人开始时间: 2014年10月28日最近更新: 2019年6月30日

试验速览

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•-Documented history of peripheral arterial disease
•-Pre-existing diagnosis of severe heart failure (LVEF<35%)
•-Malignancy under active treatment (excluding basal cell carcinoma)
•-Severe COPD (Physician diagnosis)
•-Intolerance to allopurinol
•-On long term high dose steroids (eq. Prednisolone>10mg/day due to risk of steroid induced myopathy and osteoporosis)
•-Immobility that would render the patient incapable of doing the Short Physical Performance Battery Test (SPPB) or 6MWT
•-Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded
•-Cognitive impairment precluding informed consent
•-Patients with active acute gout
•-Patients who have had allopurinol in the previous 30 days or those on long-term allopurinol
•-Patients with chronic kidney disease with an eGFR of 30ml/ or less
•-Patients who have contraindications to MRS scanning
•As the leg is the only part of the body in the scanner (unlike traditional MRI) we will not specifically exclude patients who have claustrophobia. Should they still not wish to take part, this is covered under the exclusion criteria: Any other considered by a study physician to be inappropriate for inclusion”
•-Patients who are allergic or contraindicated to GTN should be excluded from undertaking FMD
•-Any other considered by a study physician to be inappropriate for inclusion

发起方

niversity of Dundee, Tayside Clinical Trials Unit