Active Vitamin D Effect on Left Ventricular Hypertrophy

This study has been terminated.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00175149
First received: September 11, 2005
Last updated: December 5, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Secondary Hyperparathyroidism
Left Ventricular Hypertrophy
Drug: Alfacalcidiol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of 1,25 Dihydroxycholecalciferol on the Cardiovascular System in Patients With Renal Dysfunction

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The effect of dihydroxycholecalciferol on left ventricular hypertrophy [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the activity of the renin-angiotensin system [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Changes in left ventricular function [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2002
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Given alfacalcidiol. Dose adjusted after PTH level
Drug: Alfacalcidiol
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.
No Intervention: 2
The untreated arm

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175149

Locations
Denmark
Department of Renal Medicne C, Skejby Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Per Ivarsen, MD, PhD Deparment of Renam Medicine C, Skejby Hospital
Principal Investigator: Per Ivarsen, MD, PhD Deparment of Renal Medicine C, Skejby Hospital
  More Information

No publications provided

Responsible Party: Per Ivarsen, MD,ph.d., Dept of Renal Medicine C, Aarhus University Hospital, Skejby
ClinicalTrials.gov Identifier: NCT00175149     History of Changes
Other Study ID Numbers: EX 0203 DK
Study First Received: September 11, 2005
Last Updated: December 5, 2008
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
CKD 3-4

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Hypertrophy
Kidney Diseases
Hypertrophy, Left Ventricular
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Parathyroid Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical
Urologic Diseases
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Calcitriol
Dihydroxycholecalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014