NCT00641875

Brief Summary

Arterial stiffness refers to the accumulation of extracellular deposits of matrix and calcium which reduce blood vessel compliance. Although there is growing evidence that increased arterial stiffness is associated with chronic kidney disease (CKD), its pathogenesis is unclear. Pulse wave velocity (PWV) and augmentation index (AIx) provide tools for estimating arterial stiffness, and therefore predicting cardiovascular morbidity and mortality. The aims of the study are: (1) compare the effects of nocturnal and conventional haemodialysis on arterial stiffness, and (2) examine the relationship between arterial stiffness and clinical and biochemical parameters.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2005

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

March 17, 2008

Last Update Submit

April 23, 2015

Conditions

Keywords

arterial stiffnessarteryaortic pulse wave velocitypulse wave analysisaugmentation indexend stage renal diseasenocturnal hemodialysisextended hours of hemodialysiscardiovascularhemodialysis

Outcome Measures

Primary Outcomes (1)

  • To purpose of this study is to evaluate the arterial stiffness in subjects who have undergone 12 months nocturnal haemodialysis.

    12 months

Secondary Outcomes (1)

  • To examine the relationship between arterial stiffness and clinical and biochemical parameters

    12 months

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All participants are adult patients who are receiving maintenance dialysis at the North West Dialysis Service. Consecutive patients enrolled in the Nocturnal Haemodialysis program are invited to participate in the study

You may qualify if:

  • adult dialysis patients
  • able to perform home nocturnal haemodialysis

You may not qualify if:

  • age \< 18 and \> 80 years
  • any patient who is anticipating a live renal transplantation in forthcoming 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Lian, FRACP, MBBS

    Department of Nephrology, Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

December 1, 2005

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 27, 2015

Record last verified: 2015-04