NCT00354588

Brief Summary

  1. 1.Cardiovascular risk is high in patients with renal failure.
  2. 2.Cross-sectional studies have indicated a relationship between arterial stiffness and renal function. However, there are no prospective longitudinal studies in the literature.
  3. 3.In dialysis patients, arterial stiffness as well as wave reflections, predict mortality. However, there are no data on patients with mild-to-moderate renal impairment available.
  4. 4.Therefore, we designed a study to test the hypothesis that: a) measures of arterial stiffness and wave reflections predict the progression of renal impairment in patients with mild-to-moderate renal failure; and b) measures of arterial stiffness and wave reflections predict cardiovascular events in patients with mild-to-moderate renal failure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 4, 2010

Status Verified

November 1, 2010

Enrollment Period

4.8 years

First QC Date

July 19, 2006

Last Update Submit

November 3, 2010

Conditions

Chronic Renal FailureArterial StiffnessArterial Wave Reflections

Keywords

chronic renal failurearterial stiffnessarterial wave reflections

Outcome Measures

Primary Outcomes (1)

  • renal endpoint

    doubling serum creatinine, need for dialysis, renal transplantation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with chronic renal failure

You may qualify if:

  • chronic renal failure patients (KDOQI III, IV) undergoing regular control visits at our nephrology department
  • \> 19 years
  • written informed consent

You may not qualify if:

  • atrial fibrillation
  • valvular heart disease
  • severely impaired systolic function
  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology and Nephrology Department Klinikum Wels

Wels, 4600, Austria

Location

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

  • Thomas Weber, MD

    Cardiology Department, Klinikum Wels, Austria

    PRINCIPAL INVESTIGATOR

  • Manfred Wallner, MD

    Nephrology Department, Klinikum Wels, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 20, 2006

Study Start

January 1, 2006

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 4, 2010

Record last verified: 2010-11

Locations

AU(1)