Active Vitamin D Effect on Left Ventricular Hypertrophy

Phase 4TerminatedNCT00175149

Per Ivarsen24 enrolled

Overview

Left ventricular hypertrophy (LVH) predicts mortality at start of dialysis. Prevention of of LVH is important. It is not known whether secondary hyperparathyroidism might induce LVH. In the present study patients are randomised to 1.25 dihydroxycholecalciferol or no treatment to study the effect on LVH.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Secondary Hyperparathyroidism Left Ventricular Hypertrophy

Interventions

AlfacalcidiolDRUG

Alfacalcidiol are given to patientwith CKD 3-4 and secondary hyperparathyrodism. The PTH level is lowered to normal range. with increasing dose of alfacalcidiol and are followed for 6 month.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic kidney disease (S-creatinin \> 150 and \< 600 mikroM) * Secondary hyperparathyroidism (Between 3-8 times the upper limit of our PTH assay) * Stable blood pressure during the last 6 months (less than (160/95) * B-hemoglobin \> 6 mmol/l * EKG with sinus rhythm and no sign of Q-wave infarction * Expected follow up 6 month Exclusion Criteria: * Pregnancy * Kidney transplantation * Malignant disease

Locations (1)

Department of Renal Medicne C, Skejby Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

The effect of dihydroxycholecalciferol on left ventricular hypertrophy

Time frame: 6 month

Secondary Outcomes

Changes in the activity of the renin-angiotensin system

Time frame: 6 month

Changes in left ventricular function

Time frame: 6 month

Data from ClinicalTrials.gov

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