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a-Klotho in Relation to Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03858413
Recruitment Status : Completed
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
AHEPA University Hospital
Information provided by (Responsible Party):
Panagiotis Savvoulidis, Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
To define the correlation of the levels of a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve.

Condition or disease Intervention/treatment
Vascular Calcification Chronic Kidney Diseases Diagnostic Test: No intervention

Detailed Description:

Vascular calcification is a well-defined risk factor for cardiovascular disease and a-Klotho has been suggested to be an implicating factor in the process of vascular calcification, particularly in patients with chronic kidney disease (CKD).

With this study the investigators will examine the possible correlation of the levels of secreted a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve in patients with CKD at different stages of CKD. More precisely, a-Klotho was measured in 30 patients with end-stage renal disease under intermittent regular hemodialysis and 30 outpatients with stable CKD stage III (estimated glomerular filtration rate between 30 and 59 mL/min/1.73^2).

Participants in both groups were eligible only if stable for at least the last 3 months pre-enrollment. Calcification will be calculated using the well-established Agatston score after submitting all patients to multi-slice computed tomography.

Continuous variables will be described as median (25th-75th percentile) and categorical variables as N (%). Variables will be compared between groups using the non-parametric Mann-Whitney U test for continuous and Fisher's exact test for categorical variables. Bivariate correlations of a-Klotho levels with clinical variables and calcification scores using the Spearman correlation coefficient will be examined. Identification of a-Klotho determinants, log-transformation of a-Klotho levels was done because of log-normal distribution and stepwise linear regression was used, with probability to remove the variable>0.1. Identification of determinants of coronary and aortic calcification was done via log-transformation of the corresponding calcium scores, (a value of 0 was assumed; log-transformed-1 for absent calcium) and, stepwise linear regression was used as above. Because of the small sample size, all regression estimates, and confidence intervals were calculated with re-sampling so that robust variable selection and stable estimates can be ensured.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Correlation of a-Klotho Levels With the Severity of Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chronic kidney disease stage V
No intervention
Diagnostic Test: No intervention
No intervention

Chronic kidney disease stage III
No intervention
Diagnostic Test: No intervention
No intervention




Primary Outcome Measures :
  1. Agatston score in coronary arteries. [ Time Frame: During enrollment. ]

    Calcification of coronary arteries will be measured with multi-slice CT and dedicated software to calculate Agatston score.

    Initially, Hounsfield units will be measured and transformed into Agatston score net numbers.

    A brief description of the method is provided below:

    Method of calculation:

    The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by the area of the calcification speck.

    Density factor: 130-199 HU: 1; 200-299 HU: 2; 300-399 HU: 3; 400+ HU: 4. The score of every calcified speck is summed up to give the total calcium score.


  2. Agatston score in aortic valve. [ Time Frame: During enrollment. ]

    Calcification aortic valve will be measured with multi-slice CT and dedicated software to calculate Agatston score.

    Initially, Hounsfield units will be measured and transformed into Agatston score net numbers.

    A brief description of the method is provided below:

    Method of calculation:

    The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by the area of the calcification speck.

    Density factor: 130-199 HU: 1; 200-299 HU: 2; 300-399 HU: 3; 400+ HU: 4. The score of every calcified speck is summed up to give the total calcium score.


  3. Circulating a-Klotho. [ Time Frame: During enrollment. ]
    Circulating a-Klotho levels will be measured in serum with the use of a commercially available ELISA kit. Concentration will be expressed in pg/mL.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Two different populations have been selected. First group with patients with chronic kidney disease under hemodialysis. Second group with patients with chronic kidney disease stage III stable for the last at least 3 months
Criteria

Inclusion Criteria:

  • Patients with stable chronic kidney disease stage V under intermittent hemodialysis and, patients with stable chronic kidney disease stage III

Exclusion Criteria:

  • Active cancer
  • Inflammatory or granulomatous disease
  • Primary hyperparathyroidism
  • Patients unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858413


Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
AHEPA University Hospital
Investigators
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Study Director: Stavros Hadjimiltiades, Professor Head of Interventional Cardiology Department
Publications:

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Responsible Party: Panagiotis Savvoulidis, Principal Investigator, Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03858413    
Other Study ID Numbers: 16/23-6-2016
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans made to make IPD available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Calcinosis
Vascular Calcification
Urologic Diseases
Renal Insufficiency
Calcium Metabolism Disorders
Metabolic Diseases