DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Vitamin D and Cardiac Autonomic Tone in Hemodialysis

Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Disease; Sudden Cardiac Death

Intervention: Alfacalcidol (Dietary Supplement); Ergocalciferol (Dietary Supplement)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: University of Calgary

Official(s) and/or principal investigator(s):
Dr. Sofia B Ahmed, MD, MMSc, Principal Investigator, Affiliation: University of Calgary
Dr. Derek Exner, MD, MPH, Principal Investigator, Affiliation: University of Calgary, Libin Cardiovascular Institute
Dr. Brenda Hemmelgarn, MD, PhD, MN, Principal Investigator, Affiliation: University of Calgary

Summary

Despite advances in treatment of conventional cardiovascular risk factors, patients with kidney disease remain at high risk for fatal cardiac events. To date, kidney disease affects approximately 2 million Canadians; however, this patient population remains grossly understudied due to the complex nature of the disease. The inadequacy of the literature to address the cardiovascular-related mortality rates in those with kidney disease reflects the urgent need for investigation of novel risk factors. One cardiovascular risk factor which has recently been validated is the clinical measurement of cardiac autonomic tone (CAT). CAT refers to the amount of activity contributed by the stimulatory and inhibitory limbs of the cardiac autonomic nervous system, which work in concert with one another to control heart rate. CAT can be quantified computer analysis of heart rate over time, captured by a simple Holter electrocardiogram (ECG) recording. Abnormal CAT, which occurs when the autonomic system does not control heart rate properly in response to physical demands or stress, is associated with risk of adverse cardiovascular events in both healthy and high risk populations. It has recently been shown that patients with severe kidney disease demonstrate significant CAT abnormalities, thus exaggerated susceptibility to cardiac death. Vitamin D (VD) deficiency is also common in this patient population due to the fact that the kidney plays a crucial role in VD metabolism. Given that VD deficiency is an established cardiovascular risk factor on its own, it is possible that kidney disease patients experienced compounded risk due to the combination of VD deficiency and abnormal CAT. However, no study has ever investigated whether VD deficiency influences CAT in healthy or diseased populations. To our knowledge, this will be the first trial to ever examine the effect, if any, of different VD supplementation treatments (standard of care vs. combination) on CAT in a population burdened with overwhelming risk and incidence of cardiovascular and sudden cardiac death risk.

Clinical Details

Official title: Vitamin D Supplementation and Cardiac Autonomic Tone in Hemodialysis Patients: A Blinded, Randomized-controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

LF:HF

LF:HF

LF:HF

Secondary outcome:

SDNN

SDANN

pNN50%

LF

HF

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- age ≥ 18 years

- 3x weekly hemodialysis outpatient within Calgary for at least 3 months prior to

enrolment

- physician consent to participate in VD supplementation regimen

- ability and agreement to cease any VD medication for 4 weeks prior to initiation of

study

- able to comprehend study and provide oral and written consent in English

Exclusion Criteria:

- any major cardiovascular event (new onset arrhythmia, hospitalization for a cardiac

event) noted in patient chart within the 6 month period prior to initiation of the study

- currently on VD therapy/refusal to cease VD therapy for 4 weeks prior to initiation

of study

- physician anticipates death or adverse event within the next year- known discharge

from hemodialysis (transfer to peritoneal dialysis, kidney transplant)

Locations and Contacts

Foothills Medical Centre - University of Calgary, Calgary, Alberta T2N 2T9, Canada

Northland Hemodialysis Clinic, Calgary, Alberta T2L 2J8, Canada

Sheldon M. Chumir Health Centre, Calgary, Alberta T2R 0X7, Canada

Additional Information

Related publications:

Mann MC, Exner DV, Hemmelgarn BR, Turin TC, Sola DY, Ahmed SB. Impact of gender on the cardiac autonomic response to angiotensin II in healthy humans. J Appl Physiol (1985). 2012 Mar;112(6):1001-7. doi: 10.1152/japplphysiol.01207.2011. Epub 2012 Jan 5.

Drechsler C, Pilz S, Obermayer-Pietsch B, Verduijn M, Tomaschitz A, Krane V, Espe K, Dekker F, Brandenburg V, März W, Ritz E, Wanner C. Vitamin D deficiency is associated with sudden cardiac death, combined cardiovascular events, and mortality in haemodialysis patients. Eur Heart J. 2010 Sep;31(18):2253-61. doi: 10.1093/eurheartj/ehq246. Epub 2010 Aug 5.

Lahiri MK, Kannankeril PJ, Goldberger JJ. Assessment of autonomic function in cardiovascular disease: physiological basis and prognostic implications. J Am Coll Cardiol. 2008 May 6;51(18):1725-33. doi: 10.1016/j.jacc.2008.01.038. Review.

Mann MC, Exner DV, Hemmelgarn BR, Sola DY, Turin TC, Ellis L, Ahmed SB. Vitamin D levels are associated with cardiac autonomic activity in healthy humans. Nutrients. 2013 Jun 10;5(6):2114-27. doi: 10.3390/nu5062114.

Starting date: January 2013
Last updated: September 16, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017