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临床试验/NCT04472637
NCT04472637已完成2 期

Atorvastatin Effects On Arterial Stiffness In Hemodialysis Patients

Alexandria University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
change in Augmentation index (AIx)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients on regular hemodialysis treatment for more than 3 months

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Placebo (Drug)

Atorvastatin

Experimental

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

干预措施: Atorvastatin (Drug)

结局指标

主要结局

change in Augmentation index (AIx)

时间窗: 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.

change in Aortic pulse wave velocity (PWV)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Lecturer

Alexandria University

研究点 (1)

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