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Influence of Renal Function on the Circadian Variation of Cardiac Troponin

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Locations
Netherlands
Study Type
Observational
Intervention
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CKD stage 3 or 4
  • No dialysis
  • No evidence of active, acute cardiovascular disease

Exclusion Criteria:

  • History of acute myocardial infarction in the last year
  • History of pulmonary embolism in the last six months
  • Anemia (Hb < 6.5 mmol/L)

Sites / Locations

  • Maastricht University Medical Center

Outcomes

Primary Outcome Measures

Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT))

Secondary Outcome Measures

Full Information

First Posted
August 5, 2014
Last Updated
February 17, 2016
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02210897
Brief Title
Influence of Renal Function on the Circadian Variation of Cardiac Troponin
Official Title
Influence of Renal Function on the Circadian Variation of Cardiac Troponin
Study Type
Observational

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction. Whereas the diagnosis is based on an increase and/or decrease in the concentrations of cardiac troponins with at least one value above the 99th percentile value of the reference population together with the evidence of ischemia, serial sampling is needed. Knowledge of the variation in cardiac troponin levels over time in individuals in a normal rest state (not during an acute myocardial infarction), also called the biological variation, is important regarding the interpretation of the serial cardiac troponin levels. A recent study by our group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is important regarding the interpretation of the serial cardiac troponin levels. Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The mechanism of the elevated concentration of cTn in these subjects is still unclear. It is hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it is not clear whether renal function affects the biological variation and circadian rhythm of cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with impaired renal function creates the opportunity to assess the effect of renal clearance on the circadian rhythm of cardiac troponins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Enrollment
20 (Actual)
Primary Outcome Measure Information:
Title
Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT))
Time Frame
up to three months
Other Pre-specified Outcome Measures:
Title
24-hour automatic blood pressure measurements (diastolic and systolic blood pressure)
Time Frame
total time 25 hours (first testday)
Title
Urine concentrations of creatinine, electrolytes and cardiac markers
Time Frame
every 4 hours, total time 25 hours (first testday)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CKD stage 3 or 4 No dialysis No evidence of active, acute cardiovascular disease Exclusion Criteria: History of acute myocardial infarction in the last year History of pulmonary embolism in the last six months Anemia (Hb < 6.5 mmol/L)
Study Population Description
Individuals with chronic kidney disease (CKD) stage 3 and 4
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven JR Meex, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24583293
Citation
Klinkenberg LJ, van Dijk JW, Tan FE, van Loon LJ, van Dieijen-Visser MP, Meex SJ. Circulating cardiac troponin T exhibits a diurnal rhythm. J Am Coll Cardiol. 2014 May 6;63(17):1788-95. doi: 10.1016/j.jacc.2014.01.040. Epub 2014 Feb 26.
Results Reference
background
PubMed Identifier
35670217
Citation
Breidthardt T, van Doorn WPTM, van der Linden N, Diebold M, Wussler D, Danier I, Zimmermann T, Shrestha S, Kozhuharov N, Belkin M, Porta C, Strebel I, Michou E, Gualandro DM, Nowak A, Meex SJR, Mueller C. Diurnal Variations in Natriuretic Peptide Levels: Clinical Implications for the Diagnosis of Acute Heart Failure. Circ Heart Fail. 2022 Jun;15(6):e009165. doi: 10.1161/CIRCHEARTFAILURE.121.009165. Epub 2022 Jun 7.
Results Reference
derived

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Influence of Renal Function on the Circadian Variation of Cardiac Troponin

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