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临床试验/NCT04543721
NCT04543721Unknown不适用

24-h-ambulatory Blood Pressure Monitoring (24-h-ABPM) and Pulse Wave Analysis (PWA) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) to Evaluate the Individual Cardiovascular Risk Profile.

University Hospital of Cologne1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Measurmement of pulsative hemodynamics

研究概览

简要总结

Evaluation of the individual cardiovascular risk profile of patients with non-alcoholic fatty liver disease (NAFLD) using 24-hour ambulatory long-term blood pressure measurement and pulse wave analysis

详细描述

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in western industrialized countries. Globally, but also in Germany, the current prevalence of NAFLD in the adult population is about 20-30% with a continuing upward trend.

The main cause of death in patients with NAFLD include cardiovascular events and the major risk factor for the occurrence of cardiovascular events is arterial hypertension.

Besides absolute systolic and diastolic blood pressure values, disturbances of circadian blood pressure variability seem to be of particular relevance for the occurrence of cardiovascular events.

24-hour ambulatory blood pressure monitoring (24-h-ABPM) has been established as the most reliable, non-invasive method to diagnose arterial hypertension. 24-h-ABPM complements office blood pressure measurement by the option of characterizing the circadian blood pressure profile and is superior to it in terms of predicting total mortality and cardiovascular mortality. Under- or overestimation of the actual blood pressure level during individual measurements in everyday clinical practice can be avoided by using 24-h-ABPM and special hypertension phenotypes such as white coat hypertension or masked hypertension can be identified.

In addition, modern 24-h-ABPM devices allow a simultaneous pulse wave analysis (PWA) to evaluate central hemodynamic parameters such as central aortic blood pressure, systolic blood pressure augmentation and pulse wave velocity. Using these functional parameters of pulsatile hemodynamics, it is possible to determine the extent of vascular damage and the cardiovascular risk of the individual patient much earlier and more precisely.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 18 years
  • Patients with confirmed or newly diagnosed non-alcoholic fatty liver disease (NAFLD),NAFL,NASH
  • Patients with arterial hypertension, without concomitant liver disease
  • Patients with overweight or obesity (BMI ≥25) without fatty liver; the latter excluded in advance by current imaging
  • Patients with chronic hepatitis B, chronic hepatitis C, ethyltoxic liver disease, autoimmune hepatitis, cholestatic liver disease (PBC, PSC) or other chronic hepatopathy; existing liver histology is desirable, but absence is not a criterion for exclusion All patients should be of normal weight (BMI 18.5 - 24.9) and, with the exception of alcoholic liver disease, should not have fatty liver in the imaging.
  • Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, colitis indeterminata)
  • Healthy controls: no known previous illness, no permanent medication, no fatty liver (excluded in advance by current imaging), normal weight (BMI 18.5 - 24.9).
  • Present declaration of consent

排除标准

  • Failure to meet the inclusion criteria
  • A known chronic liver disease that is not described in the above mentioned collectives
  • Taking drugs that can cause fatty degeneration of the liver (e.g. methotrexate, amiodarone, tamoxifen, etc.)
  • Circumstances that do not allow the person concerned to assess the nature and extent as well as possible consequences of the clinical trial
  • Indications that the subject is unlikely to comply with the protocol (e.g., lack of cooperation)

结局指标

主要结局

Measurmement of pulsative hemodynamics

时间窗: 2019-2022

Measurmement of pulsative hemodynamics

Diagnosis of hypertension

时间窗: 2019-2022

Diagnosis of Hypertension and associated subtypes

次要结局

未报告次要终点

研究者

发起方
University Hospital of Cologne
申办方类型
Other
责任方
Principal Investigator
主要研究者

Philipp Kasper

Dr. med. Philipp Kasper, Dr. med. Anna Martin, Prof. Dr. Hans-Michael Steffen

University Hospital of Cologne

研究点 (1)

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