Atorvastatin Effects On Arterial Stiffness In Hemodialysis

April 13, 2022 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Atorvastatin Effects On Arterial Stiffness In Hemodialysis Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease (CVD) is the most common cause of morbidity and mortality among patients with end-stage renal disease (ESRD) on hemodialysis (HD).

CVD are present since the early stages of chronic kidney disease (CKD) and reach around 30 to 44% of those beginning hemodialysis. Macrovascular disease develops rapidly in uremic patients and is responsible for the high incidence of ischemic heart disease, left ventricular (LV) hypertrophy, congestive heart failure, sudden death, and stroke.

Compared with the general population, the incidence of cardiovascular (CV) events among patients with ESRD is significantly higher, but it does not seem to be fully explained by the increased incidence of conventional risk factors alone. It has been hypothesized that HD patients are exposed to unique renal and HD-related risk factors that predispose them to an increased rate of CV events. Research efforts have expanded understanding of the contribution made by vascular pathologies to this burden.

Clinicians now recognize that defects in the vascular wall are the bases of many CV events, and early detection and intervention in subclinical vascular disease are fundamental for preventing and controlling cardiovascular events. Changes in the vasculature include endothelial dysfunction (ED), smooth muscle cell hyperplasia/hypertrophy, vascular calcification, and arterial stiffness.

Arterial stiffness is one of the vascular pathologies in HD patients. Recent studies examining cardiovascular complications in dialysis patients focused on atherosclerosis, including arterial stiffness and wall thickness changes as a major contributing factors for CV events. It was shown that stiffening of arteries is associated with increased cardiovascular mortality and morbidity.

Arteriosclerosis refers to the reduced arterial compliance due to increased fibrosis, loss of elasticity, and vessel wall calcification affecting the media of large and middle-sized arteries. These arterial wall changes are influenced not only by nonspecific factors, such as age, genetics, hypertension, diabetes, lipid abnormalities, inflammation, and/or common atherosclerosis, but also by parameter(s) associated with the presence of uremia per se.

Arterial stiffening in patients with CKD and ESRD occurs at an accelerated rate compared with the normal ageing process and arteriosclerosis. As bone mineral metabolism worsens with advancement to ESRD, hyperphosphatemia, secondary hyperparathyroidism and inhibited vitamin D synthesis result in vascular calcification that causes hardening of the arteries. Other factors linked to the uremic environment, such as anaemia, endothelial dysfunction, neuro-hormonal activation and inflammation, play important roles.

Arterial stiffness can be assessed noninvasively with the use of pulse wave velocity (PWV) measurement. The aortic pulse wave velocity (APWV) reflects central arterial stiffness. APWV is a predictor of cardiovascular outcome in patients with hypertension, diabetes, end-stage renal disease, and elderly hospitalized subjects.

Statins or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors are considered first-line treatment for elevated low-density lipoprotein cholesterol (LDL-C) levels, as large-scale, randomized clinical trials have demonstrated their clinical benefits in primary and secondary prevention of cardiovascular events. Background and clinical studies have also shown beneficial actions of statins for the vasculature that may extend above their lipid lowering properties, such as improvement of endothelial function, inhibition of vascular smooth muscle cell proliferation, and reduction of vascular inflammation. It has been also proposed that such pleiotropic effects of statins may translate into a beneficial impact on arterial stiffness. Atorvastatin reduced arterial stiffness in patients with hypertension and hypercholesterolemia, diabetes mellitus. Fassett at al. found that atorvastatin reduced arterial stiffness in CKD patients (stage 2-4) but they did not include patients on maintenance haemodialysis in their study. We want to illustrate if these beneficial effects on arterial stiffness will be present or not among haemodialysis patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21526
        • Faculty of Medicine, Aexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients on regular hemodialysis treatment for more than 3 months

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Atorvastatin
They will receive atorvastatin 10 mg, as one tablet /day for 24 weeks.
Drug: Atorvastatin
atorvastatin 10 mg, as one tablet /day for 24 weeks.
Other Names:
  • Lipitor, Ator
PLACEBO_COMPARATOR: placebo
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
a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Aortic pulse wave velocity (PWV)
Time Frame: baseline, 24 weeks
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)
Time Frame: baseline, 24 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Central systolic blood pressure (CSP)
Time Frame: 24 weeks
Central aortic systolic blood pressure is a parameter that strongly reflects vascular changes of central elastic arteries compared to peripheral brachial blood pressure
24 weeks
change in Peripheral blood pressure (PBP)
Time Frame: baseline, 24 weeks
change in peripheral systolic and diastolic blood pressure
baseline, 24 weeks
change in central pulse pressure (PP)
Time Frame: baseline, 24 weeks
will be clalculated from the central waveform
baseline, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: El Hassan M Ayman, MSc, Assistant lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

July 1, 2021

Study Registration Dates

First Submitted

July 11, 2020

First Submitted That Met QC Criteria

July 11, 2020

First Posted (ACTUAL)

July 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • arterial stiffness in HD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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