Risk Assessment by Cardiovascular Biomarkers in Chronic Dialysis Patients

NCT02207153 | Completed

• 1 other identifier: EKNZ 2014-210
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Endstage Renal Disease

Keywords

Chronic Hemodialysis; Chronic Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Weekly

Secondary Outcomes (1)

• All Cause Mortality

  Weekly

Other Outcomes (1)

• Combined cardiac endpoint

  weekly

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- 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

You may not qualify if:

• Age \< 18 years
• No written informed consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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 Officials

• Tobias Breidthardt, PD Dr

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 4, 2014
• Study Start: December 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

CH (1)