<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02207153</url>
  </required_header>
  <id_info>
    <org_study_id>EKNZ 2014-210</org_study_id>
    <nct_id>NCT02207153</nct_id>
  </id_info>
  <brief_title>Risk Assessment by Cardiovascular Biomarkers in Chronic Dialysis Patients</brief_title>
  <acronym>RACE</acronym>
  <official_title>Risk Assessment by Cardiovascular Biomarkers in Chronic Dialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing chronic dialysis are at a substantially increased risk of cardiac death.&#xD;
      The reasons for this excess cardiovascular mortality are only partly understood. Classical&#xD;
      complicated artherosclerotic disease does not appear to be the primary cause of cardiac death&#xD;
      in chronic dialysis patients. In fact, the predictive potential of classic cardiovascular&#xD;
      risk factors such as hypertension, obesity and hyperlipidemia appears to be reduced in&#xD;
      dialysis. In contrast, in a series of pilot studies we found cardiac biomarkers to adequately&#xD;
      reflect dialysis induced myocardial stunning, progressive cardiovascular disease, and the&#xD;
      risk of death.&#xD;
&#xD;
      To extend and corroborate these results, we are planning a large, prospective, observational&#xD;
      study enrolling unselected hemo- and peritoneal dialysis patients. The proposed study, its&#xD;
      power calculation and hypotheses are based on our pilot studies&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be identified through the clinical care team by undergoing chronic&#xD;
      dialysis at one of the study centres. Dialysis patients will be initially approached during a&#xD;
      routine dialysis session by a member of the clinical team to discuss the study and a&#xD;
      participant information sheet will be provided. A minimum of 2 days after the provision of&#xD;
      the participant information sheet, the clinical team will inform the research team about the&#xD;
      patients who are interested in this study. Potential participants will be re-approached in&#xD;
      person by a trained research physician to determine whether they are willing to participate&#xD;
      in the study. If they are interested, the information sheet will be discussed with them and&#xD;
      any questions will be answered. The investigators will explain the nature of the study, its&#xD;
      purpose, the procedures involved, the expected duration, the potential risks and benefits and&#xD;
      any discomfort it may entail to each potential participant. Each participant will be informed&#xD;
      that the participation in the study is voluntary and that he/she may withdraw from the study&#xD;
      at any time and that withdrawal of consent will not affect his/her subsequent medical&#xD;
      assistance and treatment.&#xD;
&#xD;
      All potential study participants will be provided with a participant information sheet and a&#xD;
      consent form describing the study and providing sufficient information for the participant to&#xD;
      make an informed decision about their participation in the study.&#xD;
&#xD;
      The participant will be given a copy of the signed document. The consent form must also be&#xD;
      signed and dated by the investigator (or his designee) and it will be retained as part of the&#xD;
      study records. After consent is obtained, the participant will be allocated an unique study&#xD;
      identification (ID) code.&#xD;
&#xD;
      Patients are free to discontinue their participation in the study at any time, without having&#xD;
      to give a reason for their withdrawal.&#xD;
&#xD;
      Patient exposure will be censored for discontinuation of dialysis because of regaining renal&#xD;
      function or patient's wish, study withdrawal and transfer of the patient to a&#xD;
      non-participating dialysis unit. Patients undergoing renal transplantation during the&#xD;
      observational period will not be censored, but will be reassessed 3 and 6 months after&#xD;
      transplantation.&#xD;
&#xD;
      First, written informed consent will be obtained from the patient. After we have obtained&#xD;
      informed consent patients will undergo their standard three times weekly hemodialysis&#xD;
      sessions or their daily peritoneal dialysis session. At the time of enrolment into the trial&#xD;
      all patients will undergo a detailed clinical assessment including a medical history and a&#xD;
      physical examination. At the beginning and the end of the dialysis session, at the time of&#xD;
      the monthly routine blood tests additional venous blood samples will be collected. Serial&#xD;
      assessments will be performed in 6 monthly intervals until the enrollment target has been&#xD;
      met. After reaching the enrollment target the observational period will continue for another&#xD;
      year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>Weekly</time_frame>
    <description>Cardiac death will be defined as death due to:&#xD;
coronary artery disease&#xD;
heart failure&#xD;
arrhythmias&#xD;
sudden death&#xD;
or other heart diseases&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All Cause Mortality</measure>
    <time_frame>Weekly</time_frame>
    <description>All Cause Mortality</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Combined cardiac endpoint</measure>
    <time_frame>weekly</time_frame>
    <description>acute myocardial infarction, acute heart failure hospitalisations and cardiac death</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">217</enrollment>
  <condition>Endstage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Chronic Hemodialysis</arm_group_label>
    <description>Initiation of chronic hemodialysis or currently undergoing chronic hemodialysis at one of the study centres</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peritoneal Dialysis</arm_group_label>
    <description>Initiation of chronic peritoneal dialysis or currently undergoing chronic peritoneal dialysis at one of the study centres</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      At the beginning and the end of the dialysis session, at the time of the monthly routine&#xD;
      blood tests additional venous blood samples will be collected. All draws will be performed&#xD;
      after a three day interdialytic interval. Until the time of en bloc analysis the aliquots&#xD;
      will be stored at -80°. All study data and blood samples will be stored for 10 years after&#xD;
      study termination, for the future assessment of novel cardiovascular biomarkers. The stored&#xD;
      blood samples will be anonymised and only labelled by a barcode. This barcode be&#xD;
      unambiguously linked to the study ID code for the individual patient. There will be no direct&#xD;
      link between the original participant details and the blood sample bar code.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The data of patients undergoing chronic hemodialysis and peritoneal dialysis will be&#xD;
        analysed overall (RACE-Dial) and separately in the two substudies, RACE-HD and RACE-PD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Age ≥18 years&#xD;
&#xD;
          -  Initiation of chronic hemodialysis or currently undergoing chronic hemodialysis at one&#xD;
             of the study centres&#xD;
&#xD;
          -  Initiation of chronic peritoneal dialysis or currently undergoing chronic peritoneal&#xD;
             dialysis at one of the study centres&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  No written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Breidthardt, PD Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>BS</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>21628312</PMID>
  </reference>
  <reference>
    <citation>Breidthardt 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.</citation>
    <PMID>22822013</PMID>
  </reference>
  <reference>
    <citation>Breidthardt 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.</citation>
    <PMID>21328099</PMID>
  </reference>
  <reference>
    <citation>Breidthardt 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.</citation>
    <PMID>23880872</PMID>
  </reference>
  <reference>
    <citation>Breidthardt 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.</citation>
    <PMID>21546884</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>May 11, 2020</last_update_submitted>
  <last_update_submitted_qc>May 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hemodialysis</keyword>
  <keyword>Chronic Peritoneal Dialysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02207153
org study id: EKNZ 2014-210
nct id: NCT02207153
lead sponsor: 
has dmc: No
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
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.
observational model: Cohort
time perspective: Prospective
measure: Cardiac death
time frame: Weekly
description: 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.
measure: All Cause Mortality
time frame: Weekly
description: All Cause Mortality
measure: Combined cardiac endpoint
time frame: weekly
description: acute myocardial infarction, acute heart failure hospitalisations and cardiac death
arm group label: Chronic Hemodialysis
description: Initiation of chronic hemodialysis or currently undergoing chronic hemodialysis at one of the study centres
arm group label: Peritoneal Dialysis
description: Initiation of chronic peritoneal dialysis or currently undergoing chronic peritoneal dialysis at one of the study centres
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. All draws will be performed
      after a three day interdialytic interval. Until the time of en bloc analysis the aliquots
      will be stored at -80°. All study data and blood samples will be stored for 10 years after
      study termination, for the future assessment of novel cardiovascular biomarkers. The stored
      blood samples will be anonymised and only labelled by a barcode. This barcode be
      unambiguously linked to the study ID code for the individual patient. There will be no direct
      link between the original participant details and the blood sample bar code.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tobias Breidthardt, PD Dr
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
citation: 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.
PMID: 21628312
citation: Breidthardt 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.
PMID: 22822013
citation: Breidthardt 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.
PMID: 21328099
citation: Breidthardt 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.
PMID: 23880872
citation: Breidthardt 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.
PMID: 21546884
responsible party type: Sponsor
mesh term: Kidney Failure, Chronic