Chronic Renal FailureNCT00354588
Arterial Stiffness, Wave Reflections and Renal Failure
An observational study of Chronic Renal Failure and Arterial Stiffness, run by Klinikum Wels-Grieskirchen at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Renal Failure, Arterial Stiffness, Arterial Wave Reflections
- How many people
- 115 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2006to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic renal failure
Who may be able to join
- chronic renal failure patients (KDOQI III, IV) undergoing regular control visits at our nephrology department
- > 19 years
- written informed consent
Who cannot join
- atrial fibrillation
- valvular heart disease
- severely impaired systolic function
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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
- Keywords
- chronic renal failure, arterial stiffness, arterial wave reflections
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
renal endpoint
doubling serum creatinine, need for dialysis, renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Wels-Grieskirchen
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Weber, MD, Principal investigator, Cardiology Department, Klinikum Wels, AustriaManfred Wallner, MD, Principal investigator, Nephrology Department, Klinikum Wels, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354588
- Sponsor's protocol ID
- WelsEK 206
- Status last verified
- Nov 2010
- First submitted
- 19 Jul 2006
- Last updated
- 4 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00354588
- Acronym / sponsor ID
- WelsEK 206
- Keywords
- chronic renal failure, arterial stiffness, arterial wave reflections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Klinikum Wels-GrieskirchenUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 20 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic renal failure
Key inclusion criteria (3 listed)
- chronic renal failure patients (KDOQI III, IV) undergoing regular control visits at our nephrology department
- > 19 years
- written informed consent
Key exclusion criteria (4 listed)
- atrial fibrillation
- valvular heart disease
- severely impaired systolic function
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
renal endpoint
doubling serum creatinine, need for dialysis, renal transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Weber, MD principal investigator
Cardiology Department, Klinikum Wels, Austria
Manfred Wallner, MD principal investigator
Nephrology Department, Klinikum Wels, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure and Arterial Stiffness, run by Klinikum Wels-Grieskirchen at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal endpoint. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010; AzTrials last refreshed its copy on 31 Oct 2026.