Effect of active vitamin D (calcitriol) on left ventricular hypertrophy in type 2 diabetic patients with chronic kidney disease.

Phase 1

• Conditions: eft ventricular hypertrophy, type 2 diabetes, chronic kidney disease.; MedDRA version: 20.0Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 20.0Level: PTClassification code 10047295Term: Ventricular hypertrophySystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: LLTClassification code 10012612Term: Diabetes mellitus non insulin-depSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-003025-10-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-06
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

-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

Exclusion Criteria

-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified