Endstage Renal DiseaseRACENCT02207153
Risk Assessment by Cardiovascular Biomarkers in Chronic Dialysis Patients
An observational study of Endstage Renal Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Patients undergoing chronic dialysis are at a substantially increased risk of cardiac death. The reasons for this excess cardiovascular mortality are only partly understood. Classical complicated artherosclerotic disease does not appear to be the primary cause of cardiac death in chronic dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endstage Renal Disease
- How many people
- 217 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2016to Aug 2018
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data of patients undergoing chronic hemodialysis and peritoneal dialysis will be analysed overall (RACE-Dial) and separately in the two substudies, RACE-HD and RACE-PD.
Who may be able to join
- Age ≥18 years
- Initiation of chronic hemodialysis or currently undergoing chronic hemodialysis at one of the study centres
- Initiation of chronic peritoneal dialysis or currently undergoing chronic peritoneal dialysis at one of the study centres
- Written informed consent
Who cannot join
- Age < 18 years
- No written informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Patients undergoing chronic dialysis are at a substantially increased risk of cardiac death. The reasons for this excess cardiovascular mortality are only partly understood. Classical complicated artherosclerotic disease does not appear to be the primary cause of cardiac death in chronic dialysis patients. In fact, the predictive potential of classic cardiovascular risk factors such as hypertension, obesity and hyperlipidemia appears to be reduced in dialysis. In contrast, in a series of pilot studies we found cardiac biomarkers to adequately reflect dialysis induced myocardial stunning, progressive cardiovascular disease, and the risk of death.
To extend and corroborate these results, we are planning a large, prospective, observational study enrolling unselected hemo- and peritoneal dialysis patients. The proposed study, its power calculation and hypotheses are based on our pilot studies
Read the detailed description
Eligible patients will be identified through the clinical care team by undergoing chronic dialysis at one of the study centres. Dialysis patients will be initially approached during a routine dialysis session by a member of the clinical team to discuss the study and a participant information sheet will be provided. A minimum of 2 days after the provision of the participant information sheet, the clinical team will inform the research team about the patients who are interested in this study. Potential participants will be re-approached in person by a trained research physician to determine whether they are willing to participate in the study. If they are interested, the information sheet will be discussed with them and any questions will be answered. The investigators will explain the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail to each potential participant. Each participant will be informed that the participation in the study is voluntary and that he/she may withdraw from the study at any time and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment.
All potential study participants will be provided with a participant information sheet and a consent form describing the study and providing sufficient information for the participant to make an informed decision about their participation in the study.
The participant will be given a copy of the signed document. The consent form must also be signed and dated by the investigator (or his designee) and it will be retained as part of the study records. After consent is obtained, the participant will be allocated an unique study identification (ID) code.
Patients are free to discontinue their participation in the study at any time, without having to give a reason for their withdrawal.
Patient exposure will be censored for discontinuation of dialysis because of regaining renal function or patient's wish, study withdrawal and transfer of the patient to a non-participating dialysis unit. Patients undergoing renal transplantation during the observational period will not be censored, but will be reassessed 3 and 6 months after transplantation.
First, written informed consent will be obtained from the patient. After we have obtained informed consent patients will undergo their standard three times weekly hemodialysis sessions or their daily peritoneal dialysis session. At the time of enrolment into the trial all patients will undergo a detailed clinical assessment including a medical history and a physical examination. At the beginning and the end of the dialysis session, at the time of the monthly routine blood tests additional venous blood samples will be collected. Serial assessments will be performed in 6 monthly intervals until the enrollment target has been met. After reaching the enrollment target the observational period will continue for another year.
- Conditions
- Endstage Renal Disease
- Keywords
- Chronic Hemodialysis, Chronic Peritoneal Dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hemodialysis | Initiation of chronic hemodialysis or currently undergoing chronic hemodialysis at one of the study centres | |
| Peritoneal Dialysis | Initiation of chronic peritoneal dialysis or currently undergoing chronic peritoneal dialysis at one of the study centres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Cardiac death will be defined as death due to:
- coronary artery disease
- heart failure
- arrhythmias
- sudden death
- or other heart diseases
Sudden deaths will operationally be defined as witnessed and unwitnessed unexpected deaths, with a preceding duration of symptoms less than 24 hours for witnessed deaths, and less than the interval since the last dialysis session for unwitnessed deaths.
Measured: Weekly
Secondary outcomes (1)
All Cause Mortality
All Cause Mortality
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2014 (estimated)
- Study startDec 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 217 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Breidthardt, PD Dr, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02207153
- Sponsor's protocol ID
- EKNZ 2014-210
- Acronym
- RACE
- Status last verified
- May 2020
- First submitted
- 31 Jul 2014
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Breidthardt T, Kalbermatter S, Socrates T, Noveanu M, Klima T, Mebazaa A, Mueller C, Kiss D. Increasing B-type natriuretic peptide levels predict mortality in unselected haemodialysis patients. Eur J Heart Fail. 2011 Aug;13(8):860-7. doi: 10.1093/eurjhf/hfr057. Epub 2011 May 30.
PubMed 21628312Breidthardt T, Burton JO, Odudu A, Eldehni MT, Jefferies HJ, McIntyre CW. Troponin T for the detection of dialysis-induced myocardial stunning in hemodialysis patients. Clin J Am Soc Nephrol. 2012 Aug;7(8):1285-92. doi: 10.2215/CJN.00460112. Epub 2012 Jul 19.
PubMed 22822013Breidthardt T, Moser-Bucher CN, Praehauser C, Garzoni D, Bachler K, Steiger J, Dickenmann M, Mayr M. Morbidity and mortality on chronic haemodialysis: a 10-year Swiss single centre analysis. Swiss Med Wkly. 2011 Feb 3;141:w13150. doi: 10.4414/smw.2011.13150. eCollection 2011.
PubMed 21328099Breidthardt T, Burton JO, Odudu A, Eldehni MT, Jefferies H, McIntyre CW. N-terminal Pro-B-type natriuretic peptide and its correlation to haemodialysis-induced myocardial stunning. Nephron Clin Pract. 2013;123(1-2):118-22. doi: 10.1159/000351190. Epub 2013 Jul 18.
PubMed 23880872Breidthardt T, McIntyre CW. Dialysis-induced myocardial stunning: the other side of the cardiorenal syndrome. Rev Cardiovasc Med. 2011;12(1):13-20. doi: 10.3909/ricm0585.
PubMed 21546884
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment by Cardiovascular Biomarkers in Chronic Dialysis Patients
- ClinicalTrials.gov ID
- NCT02207153
- Acronym / sponsor ID
- RACE / EKNZ 2014-210
- Conditions
- Endstage Renal Disease
- Keywords
- Chronic Hemodialysis, Chronic Peritoneal Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 4 Aug 2014 (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.
Patients undergoing chronic dialysis are at a substantially increased risk of cardiac death. The reasons for this excess cardiovascular mortality are only partly understood. Classical complicated artherosclerotic disease does not appear to be the primary cause of cardiac death in chronic dialysis patients. In fact, the predictive potential of classic cardiovascular risk factors such as hypertension, obesity and hyperlipidemia appears to be reduced in dialysis. In contrast, in a series of pilot studies we found cardiac biomarkers to adequately reflect dialysis induced myocardial stunning, progressive cardiovascular disease, and the risk of death.
To extend and corroborate these results, we are planning a large, prospective, observational study enrolling unselected hemo- and peritoneal dialysis patients. The proposed study, its power calculation and hypotheses are based on our pilot studies
Detailed description
Eligible patients will be identified through the clinical care team by undergoing chronic dialysis at one of the study centres. Dialysis patients will be initially approached during a routine dialysis session by a member of the clinical team to discuss the study and a participant information sheet will be provided. A minimum of 2 days after the provision of the participant information sheet, the clinical team will inform the research team about the patients who are interested in this study. Potential participants will be re-approached in person by a trained research physician to determine whether they are willing to participate in the study. If they are interested, the information sheet will be discussed with them and any questions will be answered. The investigators will explain the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits and any discomfort it may entail to each potential participant. Each participant will be informed that the participation in the study is voluntary and that he/she may withdraw from the study at any time and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment.
All potential study participants will be provided with a participant information sheet and a consent form describing the study and providing sufficient information for the participant to make an informed decision about their participation in the study.
The participant will be given a copy of the signed document. The consent form must also be signed and dated by the investigator (or his designee) and it will be retained as part of the study records. After consent is obtained, the participant will be allocated an unique study identification (ID) code.
Patients are free to discontinue their participation in the study at any time, without having to give a reason for their withdrawal.
Patient exposure will be censored for discontinuation of dialysis because of regaining renal function or patient's wish, study withdrawal and transfer of the patient to a non-participating dialysis unit. Patients undergoing renal transplantation during the observational period will not be censored, but will be reassessed 3 and 6 months after transplantation.
First, written informed consent will be obtained from the patient. After we have obtained informed consent patients will undergo their standard three times weekly hemodialysis sessions or their daily peritoneal dialysis session. At the time of enrolment into the trial all patients will undergo a detailed clinical assessment including a medical history and a physical examination. At the beginning and the end of the dialysis session, at the time of the monthly routine blood tests additional venous blood samples will be collected. Serial assessments will be performed in 6 monthly intervals until the enrollment target has been met. After reaching the enrollment target the observational period will continue for another year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Hemodialysis | – | –Initiation of chronic hemodialysis or currently undergoing chronic hemodialysis at one of the study centres |
| Peritoneal Dialysis | – | –Initiation of chronic peritoneal dialysis or currently undergoing chronic peritoneal dialysis at one of the study centres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data of patients undergoing chronic hemodialysis and peritoneal dialysis will be analysed overall (RACE-Dial) and separately in the two substudies, RACE-HD and RACE-PD.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Initiation of chronic hemodialysis or currently undergoing chronic hemodialysis at one of the study centres
- Initiation of chronic peritoneal dialysis or currently undergoing chronic peritoneal dialysis at one of the study centres
- Written informed consent
Key exclusion criteria (2 listed)
- Age < 18 years
- No written 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
Cardiac death
Time frame: Weekly
Cardiac death will be defined as death due to: * coronary artery disease * heart failure * arrhythmias * sudden death * or other heart diseases Sudden deaths will operationally be defined as witnessed and unwitnessed unexpected deaths, with a preceding duration of symptoms less than 24 hours for witnessed deaths, and less than the interval since the last dialysis session for unwitnessed deaths.
1 secondary outcome
All Cause Mortality
Time frame: Weekly
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 12 May 2020.
- Background: PubMed 21628312Breidthardt T, Kalbermatter S, Socrates T, Noveanu M, Klima T, Mebazaa A, Mueller C, Kiss D. Increasing B-type natriuretic peptide levels predict mortality in unselected haemodialysis patients. Eur J Heart Fail. 2011 Aug;13(8):860-7. doi: 10.1093/eurjhf/hfr057. Epub 2011 May 30.
- Background: PubMed 22822013Breidthardt T, Burton JO, Odudu A, Eldehni MT, Jefferies HJ, McIntyre CW. Troponin T for the detection of dialysis-induced myocardial stunning in hemodialysis patients. Clin J Am Soc Nephrol. 2012 Aug;7(8):1285-92. doi: 10.2215/CJN.00460112. Epub 2012 Jul 19.
- Background: PubMed 21328099Breidthardt T, Moser-Bucher CN, Praehauser C, Garzoni D, Bachler K, Steiger J, Dickenmann M, Mayr M. Morbidity and mortality on chronic haemodialysis: a 10-year Swiss single centre analysis. Swiss Med Wkly. 2011 Feb 3;141:w13150. doi: 10.4414/smw.2011.13150. eCollection 2011.
- Background: PubMed 23880872Breidthardt T, Burton JO, Odudu A, Eldehni MT, Jefferies H, McIntyre CW. N-terminal Pro-B-type natriuretic peptide and its correlation to haemodialysis-induced myocardial stunning. Nephron Clin Pract. 2013;123(1-2):118-22. doi: 10.1159/000351190. Epub 2013 Jul 18.
- Background: PubMed 21546884Breidthardt T, McIntyre CW. Dialysis-induced myocardial stunning: the other side of the cardiorenal syndrome. Rev Cardiovasc Med. 2011;12(1):13-20. doi: 10.3909/ricm0585.
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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.
Tobias Breidthardt, PD Dr principal investigator
University Hospital, Basel, Switzerland
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 Endstage Renal Disease, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 4 inclusion and 2 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 12 May 2020. 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 Switzerland. 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?
Cardiac death (time frame: Weekly). 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 NCT02207153, which also lists 5 linked publications.
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 12 May 2020.