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

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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003025-10-GB

Enrollment

Registered

2011-09-06

Start date

2011-11-08

Completion date

Unknown

Last updated

2020-07-13

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

Conditions

Left ventricular hypertrophy, type 2 diabetes, chronic kidney disease. MedDRA version: 20.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10047295 Term: Ventricular hypertrophy System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10012612 Term: Diabetes mellitus non insulin-dep System Organ Class: 100000004861

Interventions

Trade Name: Rocaltrol Product Name: Calcitriol Pharmaceutical Form: Capsule INN or Proposed INN: calcitriol Other descriptive name: Vitamin D Concentration unit: µg microgram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main research question is to evaluate the effect of Calcitriol treatment as compared to placebo on left ventricular mass in patients with type 2 diabetes, left ventricular hyperthrophy and chronic kidney disease. Left ventricular hypertrophy is a marker and predictor of cardiovascular disease risk. Left ventricular mass will be assessed by magnetic resonance imaging. Interventions that reduce left ventricular hypertrophy may prevent cardiovascular disease. Currently it is not known if treatment with Calcitriol can affect left ventricular mass in patients with diabetes, left ventricular hypertrophy and kidney disease. We wish to study the effect of Calcitriol or placebo as add on treatment to existing medical treatments on left ventricular mass in a placebo controlled double blind study. Patients will continue with other medical treatments for their diabetes and kidney disease.;Secondary Objective: Secondary research questions will be to evaluate the effect of Calcitriol treatment as compared to placebo on interstitial myocardial fibrosis. Other secondary questions will be to compare the effect of calcitriol and placebo on augmentation left ventricular end-systolic volume, left ventricular end diastolic volume, left ventricular ejection fraction, pulse wave velocity by MRI, and if no contraindication exists cardiac perfusion. Similar to the left ventricular mass measurements all these determinations are also non invasive. Other secondary endpoints questions include blood pressure, pulse wave velocity by applanation tonometry, kidney function as measured by estimated glomerular filtration rate, changes in calcium and phosphate levels in the blood and hormones involved in regulating bone metabolism and blood pressure and quality of life as measured by a questionnaire. ;Primary end point(s): The primary end point will be left ventricular mass index. The primary population used in this assessment will be the intention to treat population. The primary	—

Measure

Time frame

Main Objective: The main research question is to evaluate the effect of Calcitriol treatment as compared to placebo on left ventricular mass in patients with type 2 diabetes, left ventricular hyperthrophy and chronic kidney disease. Left ventricular hypertrophy is a marker and predictor of cardiovascular disease risk. Left ventricular mass will be assessed by magnetic resonance imaging. Interventions that reduce left ventricular hypertrophy may prevent cardiovascular disease. Currently it is not known if treatment with Calcitriol can affect left ventricular mass in patients with diabetes, left ventricular hypertrophy and kidney disease. We wish to study the effect of Calcitriol or placebo as add on treatment to existing medical treatments on left ventricular mass in a placebo controlled double blind study. Patients will continue with other medical treatments for their diabetes and kidney disease.;Secondary Objective: Secondary research questions will be to evaluate the effect of Calcitriol treatment as compared to placebo on interstitial myocardial fibrosis. Other secondary questions will be to compare the effect of calcitriol and placebo on augmentation left ventricular end-systolic volume, left ventricular end diastolic volume, left ventricular ejection fraction, pulse wave velocity by MRI, and if no contraindication exists cardiac perfusion. Similar to the left ventricular mass measurements all these determinations are also non invasive. Other secondary endpoints questions include blood pressure, pulse wave velocity by applanation tonometry, kidney function as measured by estimated glomerular filtration rate, changes in calcium and phosphate levels in the blood and hormones involved in regulating bone metabolism and blood pressure and quality of life as measured by a questionnaire. ;Primary end point(s): The primary end point will be left ventricular mass index. The primary population used in this assessment will be the intention to treat population. The primary

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Secondary

Measure	Time frame
Secondary end point(s): •ECG Sokolow-Lyon index; •Left ventricular end-systolic volume, left ventricular end-diastolic volume, and left ventricular ejection fraction; •Myocardium perfusion (exploratory secondary endpoint); •Interstitial myocardial fibrosis; •Aortic pulse wave velocity by MRI; •Aortic pulse wave velocity by applanation tonometry; •Estimated GFR; •Serum calcium, iPTH, and active vitamin-D levels; •High sensitivity CRP; •Systolic and diastolic blood pressure; •HbA1c; •Plasma renin activity and aldosterone levels; •First-morning urine albumin-creatinine ratio; •Progression to clinical indication for vitamin D replacement or iPTH = 350 pg/ml; •Number of hypercalcaemic events requiring withdrawal from study; •Quality of life. Flow mediated dilatation, cardiac autonomic tests are exploratory secondary endpoints and will also be reported along with the above endpoints in final clinical study report (CSR);Timepoint(s) of evaluation of this end point: The trial comprise a pre screening (-6 weeks) visit that precedes the randomization visit when patients will be randomised. The patients will then be followed up for 48 weeks and will be seen at 9 visits specifically at weeks: 4, 8, 12, 16, 20, 24, 30, 36, 48.	—

Measure

Time frame

Secondary end point(s): •ECG Sokolow-Lyon index; •Left ventricular end-systolic volume, left ventricular end-diastolic volume, and left ventricular ejection fraction; •Myocardium perfusion (exploratory secondary endpoint); •Interstitial myocardial fibrosis; •Aortic pulse wave velocity by MRI; •Aortic pulse wave velocity by applanation tonometry; •Estimated GFR; •Serum calcium, iPTH, and active vitamin-D levels; •High sensitivity CRP; •Systolic and diastolic blood pressure; •HbA1c; •Plasma renin activity and aldosterone levels; •First-morning urine albumin-creatinine ratio; •Progression to clinical indication for vitamin D replacement or iPTH = 350 pg/ml; •Number of hypercalcaemic events requiring withdrawal from study; •Quality of life. Flow mediated dilatation, cardiac autonomic tests are exploratory secondary endpoints and will also be reported along with the above endpoints in final clinical study report (CSR);Timepoint(s) of evaluation of this end point: The trial comprise a pre screening (-6 weeks) visit that precedes the randomization visit when patients will be randomised. The patients will then be followed up for 48 weeks and will be seen at 9 visits specifically at weeks: 4, 8, 12, 16, 20, 24, 30, 36, 48.

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Countries

United Kingdom

Contacts

Public ContactDr Luigi Gnudi

King's College London

luigi.gnudi@kcl.ac.uk00442078484413

Outcome results

None listed

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