VItamin D in left VentrIcular hypertrophy Diabetes (VIVID) Trial.

• Research type

  Research Study

• Full title

  Effect of active vitamin-D treatment on left ventricular hypertrophy in patients with type-2 diabetes and stage-3 chronic kidney disease.

• IRAS ID

  83515

• Contact name

  Luigi Gnudi

• Sponsor organisation

  King's College London

• Eudract number

  2011-003025-10

• ISRCTN Number

  xx

• Research summary

  Summary of Research

  Patients with type-2 diabetes (T2DM) and chronic kidney disease (CKD) are at high risk of cardiovascular disease (CVD), and reduced vitamin-D activation, as seen in this population, has been proposed as a cardiovascular risk factor. Left ventricular hypertrophy (LVH) is one of the strongest risk factors for cardiovascular mortality. We hypothesise that administration of active vitamin-D will result in regression of LVH in patients with T2DM and stage-3 CKD. If this hypothesis is correct we will be in a position to justify active vitamin-D treatment for protection against LVH in this high risk population, and will establish the rationale for a larger end point driven clinical trial to formally test if active vitamin-D treatment prevents cardiovascular morbidity and mortality. We propose to study patients with a diagnosis of T2DM, aged 40 years or older, with stable chronic kidney disease (CKD) stage-3 (eGFR of 30-59 ml/min) and an ECG and MRI diagnosis of left ventricular hypertrophy (LVH) who are being treated according to the current United Kingdom National Institute for Health and Clinical Excellence (NICE) guidelines for T2DM. The study design is a prospective randomized double blind parallel group placebo controlled intervention trial with calcitriol 0.5 mcg once a day as intervention (as an add on treatment to current standard medical therapy) versus placebo. The study will last 48 weeks and will be conducted in a single centre. The primary end point will be left ventricular mass index (LVMI) measured by sequential MRI. Analysis will follow the intention to treat approach.

  Summary of Results - Awaiting

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/1296

• Date of REC Opinion

  8 Nov 2011

• REC opinion

  Further Information Favourable Opinion