Atorvastatin Effects On Arterial Stiffness In Hemodialysis

NCT04472637 | Completed Phase 2

• 1 other identifier: arterial stiffness in HD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to assess effects of atorvastatin on arterial stiffness in hemodialysis patients

Conditions

Arterial Stiffness

Keywords

statin, hemodialysis

Outcome Measures

Primary Outcomes (2)

• change in Aortic pulse wave velocity (PWV)

  the procedure was done at least 30 minutes after the dialysis session. Measurements were made after 10 minutes of rest in a supine position with a suitable cuff placed in the upper arm (the non-arteriovenous fistula arm in the hemodialysis group) and a connecting tube linking the cuff to a recorder device.Three consecutive measurements were taken automatically with 30 seconds of duration.

  baseline, 24 weeks

• change in Augmentation index (AIx)

  It is a surrogate index of arterial stiffness which measures pulse wave reflections that significantly influence the central pressure profile. It is directly related to peripheral arterial stiffness.

  baseline, 24 weeks

Secondary Outcomes (3)

• change in Central systolic blood pressure (CSP)

  24 weeks

• change in Peripheral blood pressure (PBP)

  baseline, 24 weeks

• change in central pulse pressure (PP)

  baseline, 24 weeks

Study Arms (2)

Atorvastatin

EXPERIMENTAL

They will receive atorvastatin 10 mg, as one tablet /day for 24 weeks.

Drug: Atorvastatin

placebo

PLACEBO COMPARATOR

They will receive a placebo in the form of multivitamin tablets similar to the experimental drug with the same regimen, as one tablet /day for 24 weeks.

Drug: Placebo

Interventions

Atorvastatin DRUG

atorvastatin 10 mg, as one tablet /day for 24 weeks.

Also known as: Lipitor, Ator

Atorvastatin

Placebo DRUG

a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks)

placebo

Eligibility Criteria

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

You may qualify if:

• Patients on regular hemodialysis treatment for more than 3 months

You may not qualify if:

• Patients with diabetes mellitus.
• Patients with known severe valvular heart disease.
• Irregular heart rhythm.
• History of aortic surgery/prosthetic aorta.
• Acute liver disease.
• Patients receiving lipid lowering drugs.
• Pregnancy.
• History of myocardial infraction in the previous 6 months.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine, Aexandria University

Alexandria, 21526, Egypt

Location

Related Publications (15)

• Stack AG, Bloembergen WE. Prevalence and clinical correlates of coronary artery disease among new dialysis patients in the United States: a cross-sectional study. J Am Soc Nephrol. 2001 Jul;12(7):1516-1523. doi: 10.1681/ASN.V1271516.

  PMID: 11423581 BACKGROUND

• Blacher J, Guerin AP, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness on survival in end-stage renal disease. Circulation. 1999 May 11;99(18):2434-9. doi: 10.1161/01.cir.99.18.2434.

  PMID: 10318666 BACKGROUND

• Chertow GM, Raggi P, Chasan-Taber S, Bommer J, Holzer H, Burke SK. Determinants of progressive vascular calcification in haemodialysis patients. Nephrol Dial Transplant. 2004 Jun;19(6):1489-96. doi: 10.1093/ndt/gfh125. Epub 2004 Apr 21.

  PMID: 15102961 BACKGROUND

• Simionescu M. Implications of early structural-functional changes in the endothelium for vascular disease. Arterioscler Thromb Vasc Biol. 2007 Feb;27(2):266-74. doi: 10.1161/01.ATV.0000253884.13901.e4. Epub 2006 Nov 30.

  PMID: 17138941 BACKGROUND

• Bellasi A, Ferramosca E, Ratti C. Arterial stiffness in chronic kidney disease: the usefulness of a marker of vascular damage. Int J Nephrol. 2011;2011:734832. doi: 10.4061/2011/734832. Epub 2011 May 23.

  PMID: 21660313 BACKGROUND

• Briet M, Boutouyrie P, Laurent S, London GM. Arterial stiffness and pulse pressure in CKD and ESRD. Kidney Int. 2012 Aug;82(4):388-400. doi: 10.1038/ki.2012.131.

  PMID: 22534962 BACKGROUND

• Adenwalla SF, Graham-Brown MPM, Leone FMT, Burton JO, McCann GP. The importance of accurate measurement of aortic stiffness in patients with chronic kidney disease and end-stage renal disease. Clin Kidney J. 2017 Aug;10(4):503-515. doi: 10.1093/ckj/sfx028. Epub 2017 May 10.

  PMID: 28852490 BACKGROUND

• Palaniswamy C, Selvaraj DR, Selvaraj T, Sukhija R. Mechanisms underlying pleiotropic effects of statins. Am J Ther. 2010 Jan-Feb;17(1):75-8. doi: 10.1097/MJT.0b013e31819cdc86.

  PMID: 19451808 BACKGROUND

• Sarafidis PA, Kanaki AI, Lasaridis AN. Effects of statins on blood pressure: a review of the experimental and clinical evidence. Curr Vasc Pharmacol. 2007 Apr;5(2):155-61. doi: 10.2174/157016107780368307.

  PMID: 17430220 BACKGROUND

• Kanaki AI, Sarafidis PA, Georgianos PI, Kanavos K, Tziolas IM, Zebekakis PE, Lasaridis AN. Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28.

  PMID: 23449607 BACKGROUND

• Davenport C, Ashley DT, O'Sullivan EP, McHenry CM, Agha A, Thompson CJ, O'Gorman DJ, Smith D. The Effects of Atorvastatin on Arterial Stiffness in Male Patients with Type 2 Diabetes. J Diabetes Res. 2015;2015:846807. doi: 10.1155/2015/846807. Epub 2015 Apr 30.

  PMID: 26064990 BACKGROUND

• Fassett RG, Robertson IK, Ball MJ, Geraghty DP, Sharman JE, Coombes JS. Effects of atorvastatin on arterial stiffness in chronic kidney disease: a randomised controlled trial. J Atheroscler Thromb. 2010 Mar 31;17(3):235-41. doi: 10.5551/jat.2683. Epub 2009 Dec 24.

  PMID: 20032570 BACKGROUND

• Wassertheurer S, Kropf J, Weber T, van der Giet M, Baulmann J, Ammer M, Hametner B, Mayer CC, Eber B, Magometschnigg D. A new oscillometric method for pulse wave analysis: comparison with a common tonometric method. J Hum Hypertens. 2010 Aug;24(8):498-504. doi: 10.1038/jhh.2010.27. Epub 2010 Mar 18.

  PMID: 20237499 BACKGROUND

• Hametner B, Wassertheurer S, Kropf J, Mayer C, Eber B, Weber T. Oscillometric estimation of aortic pulse wave velocity: comparison with intra-aortic catheter measurements. Blood Press Monit. 2013 Jun;18(3):173-6. doi: 10.1097/MBP.0b013e3283614168.

  PMID: 23571229 BACKGROUND

• Elsayed MM, Ayman EM. Atorvastatin can delay arterial stiffness progression in hemodialysis patients. Int Urol Nephrol. 2022 Nov;54(11):2969-2976. doi: 10.1007/s11255-022-03231-3. Epub 2022 May 18.

  PMID: 35585282 DERIVED

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Mohamed Mamdouh Elsayed, MD

  lecturer

  PRINCIPAL INVESTIGATOR

• El Hassan M Ayman, MSc

  Assistant lecturer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: a double blinded study as participants, health care providers as well as the outcome assessor will be unaware about the type of treatment each patient receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This research is a double-blinded , placebo-controlled, randomized clinical trial. Fifty patients with end-stage renal disease (ESRD) receiving hemodialysis treatment will be enrolled in the study. Patients will be randomly assigned using block randomization method into two study groups: Experimental group (25 patients): They will receive atorvastatin 10 mg, as one tablet /day for 24 weeks. Control group (25 patients): They will receive a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks). Allocation concealment: will be ensured using sealed closed envelop randomization technique, every patient will be given an identification code.

Study Record Dates

• First Submitted: July 11, 2020
• First Posted: July 15, 2020
• Study Start: November 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

EG (1)