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Do xanthine oxidase inhibitors regress left ventricular hypertrophy in diabetes? A whole new approach to reducing cardiac deaths

Do xanthine oxidase inhibitors regress left ventricular hypertrophy in diabetes? A double-blind randomised placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN96755104
Enrollment
66
Registered
2009-04-20
Start date
2009-02-02
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left ventricular hypertrophy Circulatory System Hypertensive heart disease

Interventions

Allpurinol or placebo will be given in a stepwise manner as shown below: 1. 100 mg/placebo once daily (od) for 2 weeks 2. 300 mg/placebo od for 2 weeks 3. 600 mg/placebo od for 1 year Allopurinol an

Sponsors

University of Dundee (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with type 2 diabetes 2. Patients with left ventricular hypertrophy 3. Office target blood pressure less than 150/90 mmHg at recruitment No age or gender restrictions.

Exclusion criteria

Exclusion criteria: 1. Gout 2. Already on allopurinol 3. Previous adverse reaction to allopurinol 4. Poor kidney function (estimated glomerular filtration rate [eGFR] less than 60 ml/mm) 5. Conditions that exclude magnetic resonance imaging (MRI) 6. Heart failure (left ventricular ejection fraction [LVEF] less than 45%) 7. Cancer or other life threatening illness 8. Pregnancy or breast feeding 9. Unable to provide consent

Design outcomes

Primary

MeasureTime frame
To assess if allopurinol reduces left ventricular hypertrophy in patients with diabetes

Secondary

MeasureTime frame
1. To assess if allopurinol improves endothelial function in diabetic patients will be done with flow mediated dilatation (FMD) and sphygmocor measurements. These tests will be done at time 0, 6 months and 1 year. 2. To assess if allopurinol reduces arrthymogenicity in diabetic patients will be done with a technique called microvolt T wave alternans (MTWA). This test will be done at time 0 and 1 year.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026