Arterial Stiffness, Wave Reflections and Renal Failure

Chronic Renal Failure Clinical Trial

Official title:

Observational Study on the Prognostic Significance (Renal and Cardiovascular) of Arterial Stiffness and Arterial Wave Reflections in Patients With Mild to Moderate Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354588
• Other study ID #: WelsEK 206
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: November 3, 2010
• Start date: January 2006
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Klinikum Wels-Grieskirchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Government of Upper Austria, Social Department
• Study type: Observational

Clinical Trial Summary

1. Cardiovascular risk is high in patients with renal failure.

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. 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Stiffness
• Arterial Wave Reflections
• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
Austria	Cardiology and Nephrology Department Klinikum Wels	Wels

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Wels-Grieskirchen

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal endpoint	doubling serum creatinine, need for dialysis, renal transplantation		No