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临床试验/NCT05936164
NCT05936164尚未招募不适用

The Nigeria National Registry of Atrial Fibrillation

University College Hospital, Ibadan0 个研究点目标入组 4,000 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
4,000
主要终点
All cause mortality

研究概览

简要总结

Atrial fibrillation is the most common sustained cardiac arrhythmia (rhythm abnormality) encountered in clinical practice. It contributes significantly to the risk of cardiac symptoms, hospital admissions, cardiovascular related morbidity and mortality and increased healthcare cost.

AF has significant impact on healthcare cost. The major drivers of the cost are hospitalisations, stroke and loss of productivity. Globally AF accounts for less than 1% of all deaths. However, because it co-exists with other conditions, it contributes to worse prognosis compared to persons who do not have AF. New onset AF in HF patients may be associated with particularly poor prognosis.

Most of the published data and current knowledge on AF epidemiology are based on studies in Europe and North America. The information obtainable from previous studies in sub-Saharan Africa is limited. Many of the studies were retrospective. There is also paucity of information on burden of AF (both in hospital and community), clinical profile and outcome of AF in Nigeria in particular and Africa in general.

The primary objective of this study is to determine the clinical characteristics, outcome as well as cost genetic features of AF in Nigeria.

The project will provide information on: i. Hospital and community burden of AF in Nigeria; ii. Clinical features, mode of presentation and risk factors for AF; iii. Provide data on AF related outcomes as well as prognostic factors.

详细描述

Background to the Research Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia (rhythm abnormality) encountered in clinical practice. (1) It contributes significantly to the risk of cardiac symptoms, hospital admissions, cardiovascular related morbidity and mortality and increased healthcare cost. (1, 2) In 2010, the Global Burden of Disease (GBD) study estimated that about 33.5 million people have AF globally which represents about 0.5% of the world population. (2) The increasing rate of AF has been attributed to the ageing of the world population, rise in the burden of cardiovascular risk factors such as overweight/obesity, high blood pressure, diabetes mellitus etc. (1, 2) In 2010, the Global Burden of Disease (GBD) study estimated that about 33.5 million people have AF globally. Between 1990 and 2010, the total number of deaths associated with AF in sub-Saharan Africa (SSA) increased from 441 to 1227 (196% change) The age standardized death rate (per 100,00) associated with AF rose from 0.4 to 0.6 (50% change) between 1990 and 2013. (1) Nigeria contributes to a large proportion of AF in SSA and little attention has been paid to this huge health problem.

Statement of the Problem AF has been shown to be associated with increased morbidity (especially increased association with the risk of development of heart failure (HF) and stroke, in addition to increased risk of mortality. AF is also a significant public health problem based on the fact that it accounts for about 1% of the National Health Service budget in many countries. In the United States of America (USA), the management of AF consumes about 16-26 billion dollars annually. The recent global burden of disease report has provided evidence of progressive increases in the overall burden, incidence, prevalence as well as AF associated mortality in ten-year period (1990-2010) in Africa and Nigeria contributes to a large proportion of this. Aging of the population is associated with vascular disease due to hypertension, atherosclerosis and other CVD risk factors which increase arterial stiffness, cause diastolic dysfunction and atrial volume overload resulting in AF. Most of the published data and current knowledge on AF epidemiology are based on studies in Europe and North America. The information obtainable from previous studies in sub-Saharan Africa is limited. Many of the studies were retrospective. There is also paucity of information on burden of AF (both in hospital and community), clinical profile and outcome of AF in Nigeria in particular and Africa in general.

Objectives of the Research Primary Objective The primary objective of this study is to determine the clinical characteristics, outcome as well as cost genetic features of AF in Nigeria.

Secondary Objectives-

  1. To determine the hospital prevalence, clinical features and modes of presentation of AF in Nigeria.
  2. To conduct and determine the community prevalence of AF in Nigeria
  3. To determine the risk factors of AF in Nigeria.
  4. To determine the complications of AF in Nigeria
  5. To ascertain the mode of management of AF in Nigeria.
  6. To determine the 12-months outcome of the condition and develop predictive models of outcome for AF in the country.

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
15 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All cases of confirmed atrial fibrillation

排除标准

  • Refusal of consent

结局指标

主要结局

All cause mortality

时间窗: 12 months

All deaths

次要结局

  • Stroke(12 months)
  • Any other thromboembolic events(12 months)
  • Hospitalisation(At 12 months)

研究者

发起方
University College Hospital, Ibadan
申办方类型
Other
责任方
Principal Investigator
主要研究者

O.S Ogah

DR

University College Hospital, Ibadan

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