a-Klotho in Relation to Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease
NCT ID: NCT03858413
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2016-01-15
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Chronic kidney disease stage V
No intervention
No intervention
No intervention
Chronic kidney disease stage III
No intervention
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inflammatory or granulomatous disease
* Primary hyperparathyroidism
* Patients unable to provide informed consent
18 Years
ALL
No
Sponsors
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AHEPA University Hospital
OTHER
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Panagiotis Savvoulidis
Principal Investigator
Principal Investigators
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Stavros Hadjimiltiades, Professor
Role: STUDY_DIRECTOR
Head of Interventional Cardiology Department
References
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Kuro-o M, Matsumura Y, Aizawa H, Kawaguchi H, Suga T, Utsugi T, Ohyama Y, Kurabayashi M, Kaname T, Kume E, Iwasaki H, Iida A, Shiraki-Iida T, Nishikawa S, Nagai R, Nabeshima YI. Mutation of the mouse klotho gene leads to a syndrome resembling ageing. Nature. 1997 Nov 6;390(6655):45-51. doi: 10.1038/36285.
Shiraki-Iida T, Aizawa H, Matsumura Y, Sekine S, Iida A, Anazawa H, Nagai R, Kuro-o M, Nabeshima Y. Structure of the mouse klotho gene and its two transcripts encoding membrane and secreted protein. FEBS Lett. 1998 Mar 6;424(1-2):6-10. doi: 10.1016/s0014-5793(98)00127-6.
Olejnik A, Franczak A, Krzywonos-Zawadzka A, Kaluzna-Oleksy M, Bil-Lula I. The Biological Role of Klotho Protein in the Development of Cardiovascular Diseases. Biomed Res Int. 2018 Dec 24;2018:5171945. doi: 10.1155/2018/5171945. eCollection 2018.
Henaut L, Chillon JM, Kamel S, Massy ZA. Updates on the Mechanisms and the Care of Cardiovascular Calcification in Chronic Kidney Disease. Semin Nephrol. 2018 May;38(3):233-250. doi: 10.1016/j.semnephrol.2018.02.004.
Mencke R, Hillebrands JL; NIGRAM consortium. The role of the anti-ageing protein Klotho in vascular physiology and pathophysiology. Ageing Res Rev. 2017 May;35:124-146. doi: 10.1016/j.arr.2016.09.001. Epub 2016 Sep 28.
Navarro-Garcia JA, Fernandez-Velasco M, Delgado C, Delgado JF, Kuro-O M, Ruilope LM, Ruiz-Hurtado G. PTH, vitamin D, and the FGF-23-klotho axis and heart: Going beyond the confines of nephrology. Eur J Clin Invest. 2018 Apr;48(4). doi: 10.1111/eci.12902. Epub 2018 Feb 21.
Kuro-O M. The FGF23 and Klotho system beyond mineral metabolism. Clin Exp Nephrol. 2017 Mar;21(Suppl 1):64-69. doi: 10.1007/s10157-016-1357-6. Epub 2016 Nov 12.
Back M, Aranyi T, Cancela ML, Carracedo M, Conceicao N, Leftheriotis G, Macrae V, Martin L, Nitschke Y, Pasch A, Quaglino D, Rutsch F, Shanahan C, Sorribas V, Szeri F, Valdivielso P, Vanakker O, Kempf H. Endogenous Calcification Inhibitors in the Prevention of Vascular Calcification: A Consensus Statement From the COST Action EuroSoftCalcNet. Front Cardiovasc Med. 2019 Jan 18;5:196. doi: 10.3389/fcvm.2018.00196. eCollection 2018.
Olauson H, Mencke R, Hillebrands JL, Larsson TE. Tissue expression and source of circulating alphaKlotho. Bone. 2017 Jul;100:19-35. doi: 10.1016/j.bone.2017.03.043. Epub 2017 Mar 18.
Other Identifiers
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16/23-6-2016
Identifier Type: -
Identifier Source: org_study_id