Arterial Stiffness, Wave Reflections and Renal Failure | NCT00354588

Studies
Arterial Stiffness, Wave Reflections and Renal Failure

NCT00354588

Sponsor

Klinikum Wels-Grieskirchen

Status

Completed

Last Update Posted

Nov 4, 2010Estimated

Enrollment

115Actual

Phase

Not provided

Conditions

Chronic Renal Failure
Arterial Stiffness
Arterial Wave Reflections

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jul 19, 2006

First Submission Date that Met QC Criteria

Jul 19, 2006

First Posted Date

Jul 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2010

Last Update Posted Date

Nov 4, 2010Estimated

Description Module

Brief Summary

Cardiovascular risk is high in patients with renal failure.
Cross-sectional studies have indicated a relationship between arterial stiffness and renal function. However, there are no prospective longitudinal studies in the literature.
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.
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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
renal endpoint	doubling serum creatinine, need for dialysis, renal transplantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with chronic renal failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Weber, MD	Cardiology Department, Klinikum Wels, Austria	Principal Investigator
Manfred Wallner, MD	Nephrology Department, Klinikum Wels, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology and Nephrology Department Klinikum Wels		Wels		4600	Austria

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided