Chronic Kidney DiseaseNCT00794872
Chemoreflex Sensitivity in Chronic Kidney Disease
An observational study of Chronic Kidney Disease and Cardiovascular Morbidity, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD) and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex sensitivity (CHRS) has been attributed to an increased sympathetic activity. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Cardiovascular Morbidity
- What is being tested?
- blood sampling
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Nov 2008
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients suffering from CDK stage 3 (GFR 30-59 ml/min/1.73 m²) or stage 4 (GFR 15-29 ml/min/1.73 m²)
- For the reference Patients without evidence for CDK
Who cannot join
- Patients with heart failure, history of myocardial infarction or instable angina pectoris, atrial fibrillation, hyperthyroidism, chronic pulmonary diseases, sleep apnoea syndrome, alcohol abuse and drug induced cardiomyopathy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Hyperoxic Chemoreflex Sensitivity in Chronic Kidney Disease
Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD) and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the present study is to examine whether chemosensor function is altered in patients with stage 3 and stage 4 CKD.
Read the detailed description
Impaired hyperoxic chemoreflex sensitivity (CHRS) is assessed in patients with stage 3 CKD [glomerular filtration rate (GFR) 30-59 ml/min/1.73 m2], in patients with stage 4 CKD [GFR 15-29 ml/min/1.73 m2], as well as in patients without any evidence of CKD. CHRS is measured by determination of the venous partial pressure of oxygen and the heart rate before and after deactivation of the chemoreceptors by inhalation of pure oxygen. The difference in the R-R intervals before and after inhalation divided by the difference in the oxygen pressures is calculated as the CHRS. A CHRS below 3.0 ms/mmHg is defined as pathological. It should be shown that using a simple clinical bedside test we provide the first evidence for impaired hyperoxic chemoreflex sensitivity in stage 3 and 4 chronic kidney disease. We thereby may lay the basis for future intervention studies assessing chemosensor function in these patients.
- Conditions
- Chronic Kidney Disease, Cardiovascular Morbidity
- Being tested
- blood sampling
- Keywords
- Cardiovascular autonomic neuropathy, Chemoreflex sensitivity, Chronic kidney disease, Sudden cardiac arrest
- Medical subject headings
- Renal Insufficiency, Chronic, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with stage 3 CKD Receives: Other: blood sampling | |
| 2 | Patients with stage 4 CKD Receives: Other: blood sampling | |
| 3 | Patients without evidence for CDK Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startJan 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, SLK Kliniken Heilbronn GmbH
- Investigators
- Christian Meyer, MD, Principal investigator, RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794872
- Sponsor's protocol ID
- Chemoreflex-Sensitivity-Study
- Status last verified
- Nov 2008
- First submitted
- 19 Nov 2008
- Last updated
- 20 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperoxic Chemoreflex Sensitivity in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00794872
- Acronym / sponsor ID
- Chemoreflex-Sensitivity-Study
- Conditions
- Chronic Kidney Disease, Cardiovascular Morbidity
- Keywords
- Cardiovascular autonomic neuropathy, Chemoreflex sensitivity, Chronic kidney disease, Sudden cardiac arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf, SLK Kliniken Heilbronn GmbH
- Study start
- Jan 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Nov 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.
Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD) and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the present study is to examine whether chemosensor function is altered in patients with stage 3 and stage 4 CKD.
Detailed description
Impaired hyperoxic chemoreflex sensitivity (CHRS) is assessed in patients with stage 3 CKD [glomerular filtration rate (GFR) 30-59 ml/min/1.73 m2], in patients with stage 4 CKD [GFR 15-29 ml/min/1.73 m2], as well as in patients without any evidence of CKD. CHRS is measured by determination of the venous partial pressure of oxygen and the heart rate before and after deactivation of the chemoreceptors by inhalation of pure oxygen. The difference in the R-R intervals before and after inhalation divided by the difference in the oxygen pressures is calculated as the CHRS. A CHRS below 3.0 ms/mmHg is defined as pathological. It should be shown that using a simple clinical bedside test we provide the first evidence for impaired hyperoxic chemoreflex sensitivity in stage 3 and 4 chronic kidney disease. We thereby may lay the basis for future intervention studies assessing chemosensor function in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: blood samplingPatients with stage 3 CKD |
| 2 | – | Other: blood samplingPatients with stage 4 CKD |
| 3 | – | Other: blood samplingPatients without evidence for CDK |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffering from CDK stage 3 (GFR 30-59 ml/min/1.73 m²) or stage 4 (GFR 15-29 ml/min/1.73 m²)
- For the reference Patients without evidence for CDK
Key exclusion criteria (1 listed)
- Patients with heart failure, history of myocardial infarction or instable angina pectoris, atrial fibrillation, hyperthyroidism, chronic pulmonary diseases, sleep apnoea syndrome, alcohol abuse and drug induced cardiomyopathy
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 sampling | Other | 1, 2, 3 |
Primary outcome
Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease
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 20 Nov 2008.
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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 Departement of Cardiology, Pulmonology and Vascular Medicine
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 Kidney Disease and Cardiovascular Morbidity, 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 2 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 20 Nov 2008. 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?
Hyperoxic chemoreflex sensitivity is impaired in patients with moderate to severe chronic kidney disease. 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 20 Nov 2008.