HemodialysisNCT00764192
Influence of Hemodialysis on Endothel-Depending Dilatation of Peripheral Arteries
A study testing blood sample and Flow-mediated dilation (FMD) before and after a single HD in people with Hemodialysis, run by RWTH Aachen University at 1 site in Germany.
Trial summary
An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction and may contribute to the excessive incidence of cardiovascular complication in chronic haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide bioavailability during HD. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- blood sample and Flow-mediated dilation (FMD) before and after a single HD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to Oct 2007
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older 21 years dependent on HD for more than 6 months
Who cannot join
- known HD associated hypotension intake of nitrate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Angiologic Study of the Influence of Hemodialysis on Endothelial Function
An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction and may contribute to the excessive incidence of cardiovascular complication in chronic haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide bioavailability during HD.
Read the detailed description
Cardiovascular complications are the major cause of death in end-stage renal disease (ESRD) patients undergoing chronic haemodialysis (HD).1 During haemodialysis (HD) the endothelium is the first organ to sense and to be impaired by mechanical and immunological stimuli.2 Adequate endothelial function and integrity reduce thromboembolic events, while endothelial dysfunction is an early key step in the development of atherosclerosis3-5, is involved in plaque progression6 and has been attributed to impaired nitric oxide (NO) bioactivity and enhanced formation of oxygen-derived free radicals.7 Given that endothelial dysfunction is at least in part reversible, the assessment of altered NO availability is of important diagnostic and prognostic significance and may deepen the understanding of cardiovascular disease in HD.8 Nitric oxide bioavailability has been shown to be limited by cell-free hemoglobin.9 The rates of NO consumption by cell-free and intraerythrocytic hemoglobin suggest that only when hemoglobin is physically compartmentalized within erythrocytes will NO produced by endothelial cells reach concentrations within smooth muscle necessary to activate guanylyl cyclase and cause vasodilation.10;11 However, the rate of NO scavenging is reduced 1,000-fold by sequestering hemoglobin within the red cell membrane.12;13 This mechanism is believed to be important in various conditions of health and disease.14-16 In ESRD intravascular hemolysis during HD has been described.17-19
- Conditions
- Hemodialysis
- Being tested
- blood sample, Flow-mediated dilation (FMD) before and after a single HD
- Keywords
- hemodialysis, Flow-mediated dilation, nictric oxide, endothelial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
Also called biochemistry
blood sample before and after a single HD
Flow-mediated dilation (FMD) before and after a single HDProcedure or surgery
Also called endothelial function
measuring of the flow-mediated dilation using high-resolution ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 14 HD patients are studied before and after a single HD using a polysulphone dialyser. Receives: Procedure: blood sample; Procedure: Flow-mediated dilation (FMD) before and after a single HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
influence of hemodialysis on endothelial function as determined by plasma nitrite concentration
Measured: before and after hemodialysis
Secondary outcomes (1)
influence on hemodialysis on endothelial function as determined by measurement of flow-mediated dilation (FMD) of teh brachial artery using high resolution ultrasound
Measured: before and after hemodialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startOct 2006
- Primary completionFeb 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Meyer, MD, Principal investigator, RWTH Aachen University, Medical Clinic I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764192
- Sponsor's protocol ID
- EK DD 2022 CM
- Status last verified
- Jan 2009
- First submitted
- 26 Sep 2008
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Meyer C, Heiss C, Drexhage C, Kehmeier ES, Balzer J, Muhlfeld A, Merx MW, Lauer T, Kuhl H, Floege J, Kelm M, Rassaf T. Hemodialysis-induced release of hemoglobin limits nitric oxide bioavailability and impairs vascular function. J Am Coll Cardiol. 2010 Feb 2;55(5):454-9. doi: 10.1016/j.jacc.2009.07.068.
PubMed 20117459
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiologic Study of the Influence of Hemodialysis on Endothelial Function
- ClinicalTrials.gov ID
- NCT00764192
- Acronym / sponsor ID
- EK DD 2022 CM
- Conditions
- Hemodialysis
- Keywords
- hemodialysis, Flow-mediated dilation, nictric oxide, endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Study start
- Oct 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 1 Oct 2008 (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.
An impairment of nitric oxide (NO) bioavailability is associated with endothelial dysfunction and may contribute to the excessive incidence of cardiovascular complication in chronic haemodialysis (HD) patients. It is not known whether cell-free hemoglobin limits nitric oxide bioavailability during HD.
Detailed description
Cardiovascular complications are the major cause of death in end-stage renal disease (ESRD) patients undergoing chronic haemodialysis (HD).1 During haemodialysis (HD) the endothelium is the first organ to sense and to be impaired by mechanical and immunological stimuli.2 Adequate endothelial function and integrity reduce thromboembolic events, while endothelial dysfunction is an early key step in the development of atherosclerosis3-5, is involved in plaque progression6 and has been attributed to impaired nitric oxide (NO) bioactivity and enhanced formation of oxygen-derived free radicals.7 Given that endothelial dysfunction is at least in part reversible, the assessment of altered NO availability is of important diagnostic and prognostic significance and may deepen the understanding of cardiovascular disease in HD.8 Nitric oxide bioavailability has been shown to be limited by cell-free hemoglobin.9 The rates of NO consumption by cell-free and intraerythrocytic hemoglobin suggest that only when hemoglobin is physically compartmentalized within erythrocytes will NO produced by endothelial cells reach concentrations within smooth muscle necessary to activate guanylyl cyclase and cause vasodilation.10;11 However, the rate of NO scavenging is reduced 1,000-fold by sequestering hemoglobin within the red cell membrane.12;13 This mechanism is believed to be important in various conditions of health and disease.14-16 In ESRD intravascular hemolysis during HD has been described.17-19
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: blood sample, Procedure: Flow-mediated dilation (FMD) before and after a single HD14 HD patients are studied before and after a single HD using a polysulphone dialyser. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients older 21 years dependent on HD for more than 6 months
Key exclusion criteria (1 listed)
- known HD associated hypotension intake of nitrate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleAlso: biochemistryblood sample before and after a single HD | Procedure or surgery | 1 |
| Flow-mediated dilation (FMD) before and after a single HDAlso: endothelial functionmeasuring of the flow-mediated dilation using high-resolution ultrasound | Procedure or surgery | 1 |
Primary outcome
influence of hemodialysis on endothelial function as determined by plasma nitrite concentration
Time frame: before and after hemodialysis
1 secondary outcome
influence on hemodialysis on endothelial function as determined by measurement of flow-mediated dilation (FMD) of teh brachial artery using high resolution ultrasound
Time frame: before and after hemodialysis
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 13 Jan 2009.
- Derived from this study: PubMed 20117459Meyer C, Heiss C, Drexhage C, Kehmeier ES, Balzer J, Muhlfeld A, Merx MW, Lauer T, Kuhl H, Floege J, Kelm M, Rassaf T. Hemodialysis-induced release of hemoglobin limits nitric oxide bioavailability and impairs vascular function. J Am Coll Cardiol. 2010 Feb 2;55(5):454-9. doi: 10.1016/j.jacc.2009.07.068.
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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.
Christian Meyer, MD principal investigator
RWTH Aachen University, Medical Clinic I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and Flow-mediated dilation (FMD) before and after a single HD in people with Hemodialysis, run by RWTH Aachen University at 1 site in Germany.
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 1 inclusion and 1 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 13 Jan 2009. 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 Germany. 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?
influence of hemodialysis on endothelial function as determined by plasma nitrite concentration (time frame: before and after hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764192, which also lists 1 linked publication.
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 13 Jan 2009; AzTrials last refreshed its copy on 8 Nov 2026.