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Allopurinol in Functional Impairment (ALFIE) Trial: 'Improving Muscle Strength'

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr. Jacob George, University of Dundee
ClinicalTrials.gov Identifier:
NCT01550107
First received: March 7, 2012
Last updated: November 10, 2014
Last verified: November 2014

March 7, 2012
November 10, 2014
December 2014
August 2017   (final data collection date for primary outcome measure)
Improvement in Muscle energetics as measured by MR-spectroscopy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
PCr repletion,Post-exercise muscle perfusion via arterial spin labelling (ASL) Pi/PCr ratio (a measure of ADP levels) Change in muscle volume (as measured by cross-sectional area on MR obtained during perfusion mapping)
Improvement in Muscle energetics as measured by MR-spectroscopy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
PCr repletion,Post-exercise muscle perfusion via arterial spin labelling (ASL) Pi/PCr ratio (a measure of ADP levels) Change in muscle volume (as measured by cross-sectional area on MR obtained during perfusion mapping) Short Performance Battery test
Complete list of historical versions of study NCT01550107 on ClinicalTrials.gov Archive Site
  • Short Performance Battery test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 6-Minute Walk Test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Flow Mediated Dilatation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Markers of oxidative stress (F2-Isoprostanes) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life measured by EuroQOL EQ5D questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Allopurinol in Functional Impairment (ALFIE) Trial: 'Improving Muscle Strength'
A Prospective Study to Evaluate the Effect of Allopurinol on Muscle Energetics in Primary Sarcopenia

Sarcopenia is defined as the presence of low muscle mass and either decreased muscle strength or function. It is increasingly becoming a significant cause of frailty, loss of independence and physical disability in ageing western populations. Recent experimental evidence has revealed that skeletal muscle is particularly susceptible to damaging molecules that result in oxidative stress and that oxidative stress plays a prominent role in the development and progression of sarcopenia. The investigators have previously shown that the xanthine oxidase inhibitor allopurinol is able to abolish vascular oxidative stress and improve endothelial function in cohorts such as optimally treated chronic heart failure and chronic kidney disease. Recently, the investigators have also shown that allopurinol improves exercise tolerance and time to ST-depression in optimally treated coronary artery disease, suggesting that allopurinol could also exert its effects through ATP and/or oxygen sparing mechanisms.

Therefore, we propose a randomised double blind placebo-controlled parallel group trial of allopurinol in patients with primary sarcopenia using MR-spectroscopy and Flow Mediated Dilatation to investigate the possible mechanisms that underlie this exciting possibility

this section will be completed once the study is officially recruiting

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sarcopenia
  • Drug: Allopurinol
    300mg b.d for 24 weeks
  • Drug: Lactose tablets
    matched placebo tablets b.d
  • Active Comparator: Allopurinol
    Allopurinol 600mg tablets
    Intervention: Drug: Allopurinol
  • Placebo Comparator: Lactose tablets
    Placebo Lactose tablets
    Intervention: Drug: Lactose tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
124
August 2017
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

Age 65 and over 6-Minute Walk Distance <400m

Exclusion Criteria:

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. Individuals with Active Acute Gout currently taking allopurinol; or those who have stopped taking allopurinol ≤1month previously for this condition.

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. Any other considered by a study physician to be inappropriate for inclusion.

Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01550107
GEO006
No
Dr. Jacob George, University of Dundee
University of Dundee
Not Provided
Principal Investigator: Jacob George, MRCP MD University of Dundee
Study Director: Allan Struthers, MD FRCP University of Dundee
Study Director: Marion McMurdo, MD FRCP University of Dundee
Study Director: Miles Witham, PhD FRCP University of Dundee
Study Director: Graeme Houston, FRCP FRCR University of Dundee
Study Director: Steve Gandy, PhD University of Dundee
Study Director: Peter Donnan, PhD FRSS University of Dundee
Principal Investigator: Clare Clarke, PhD MCSP University of Dundee
University of Dundee
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP