EUCTR2011-003025-10-GB进行中（未招募）1 期
Effect of active vitamin-D treatment on left ventricular hypertrophy in patients with type-2 diabetes and stage-3 chronic kidney disease. - VItamin D in left VentrIcular hypertrophy Diabetes (VIVID) Trial.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients with a diagnosis of T2DM;
- •-Patients aged = 40 years old (inclusive);
- •-Chronic Kidney disease (CKD) stage 3 [estimated glomerular filtration rate (eGFR*) 30-59 ml/min on the two most recent (within 12 months) consecutive measurements];
- •-A history of an elevated urinary albumin excretion rate (UAER) [albumin: creatinine ratio = 2.5 mg/mmol in men and = 3mg/mmol in women on more than three occasions or UAER = 20mcg/min on at least two timed urine collections, or two or more positive urine dipsticks results for proteinuria or two or more urine protein creatinine ratios (PCR)>15 mg/mmol] or clinical diagnosis of diabetic nephropathy.
- •-Normal corrected serum calcium (2.1-2.6mmol/l);
- •-Normal phosphate (0.8-1.5 mmol/l) levels;
- •-Intact parathyroid hormone (iPTH) level between 30 pg/ml and 300 pg/ml at screening visit or a history of a raised iPTH level between 30 pg/ml and 300 pg/ml in the 3 months preceding screening visit;
- •-History of LVH as defined by on ECG (The Sokolow-Lyon index (46): S in V1 + R in V5 or V6 -whichever is larger- = 35 mV) or R wave in lead AVL >1mV (48) or , and MRI criteria (>67g/m2 for female; >76g/m2 for males)(49) or increased posterior wall thickness =1.1 cm in men or =1.0 in women on echocardiography ;
- •-Anti-hypertensive therapy with inhibitors of the renin angiotensin system (RAS), on a stable dose for at least 1 month prior to randomisation;
- •-Written informed consent to participate in the study prior to any study procedures;
- •-Ability to communicate and comply with all study requirements.
- •*eGFR calculated by 4 variable MDRD equation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •-No evidence of LVH
- •-History (in the previous 2 months) or current vitamin-D replacement;
- •-Poorly controlled hypertension (systolic and diastolic blood pressure >180mmHg and >110 mmHg respectively);
- •-Patients is expected to receive an increase in the dose of renin-angiotensin-system (RAS) inhibitors during the course of study;
- •-Hypercalcaemia (corrected calcium >2.6mmol/l);
- •-Pre-existing known valvular heart disease, rhythm disturbances, pericardial effusion, structural heart disease;
- •-Any acute concurrent illness in the previous 6 months (e.g. malignancy, severe gastrointestinal disease);
- •-iPTH > 300 pg/ml;
- •-Contraindications to cardiac MRI;
- •-History of non-diabetic or obstructive kidney disease;
- •-Pregnancy or lactation;
- •-History of a cardiovascular or cerebrovascular event in the preceding 6 months;
- •-Patients not willing to use appropriate contraception.
研究者
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