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临床试验/NCT05936957
NCT05936957招募中不适用

The Ibadan Acute and Chronic Heart Failure Project

University College Hospital, Ibadan1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

Contemporary studies from South Africa and Nigeria have built on historical reports to demonstrate that the etiology and indeed case profile of acute HF (i.e. more women and younger individuals affected in the prime of their life) is different from high-income countries. As such, HF is now responsible for 7-10% of medical admissions in the region.

These are entirely based on studies on acute HF and few on chronic HF. The nexus between endemic infections such as tuberculosis (TB) and HIV/AIDS and other non-communicable or non-infectious risk factors and HF in Africa is scarcely documented.

This study will assess the long-term outcomes, risk factors, clinical phenotypes, and genomics of HF in Ibadan, Nigeria, estimate catastrophic healthcare cost associated with CHF and how it affects evidence-based care; understand cultural and social conceptions of HF in the city and by extension in Nigeria.

Data from each subject shall be obtained using a uniform and standardized case report forms (CRF). A detailed clinical documentation on cases of HF will be undertaken.

All variables will be summarized using appropriate descriptive statistics. Means and proportions will be estimated with two-tailed 95% confidence intervals. Specified patients' outcomes will also be summarized using proportions. Factors associated wit patient outcomes will be investigated using multivariable logistic regression models. Crude and adjusted Odds Ratio (OR) with 95% confidence intervals (CI) will be estimated.

The primary event outcome of the study will be mortality by cause. Secondary event outcomes will include non-fatal major events (both resulting in and not resulting in admission).

详细描述

Background and Purpose Heart failure (HF) has emerged a major global public health problem.(1,2) HF affects over 64 million people worldwide. (3) It is a highly symptomatic syndrome that affects 2-3% of the population in high income countries especially in people above the age of 65 years. (4 5) Until recently, little was known about the emerging problem of non-communicable forms of HF supplementing traditional pathways to the syndrome in sub-Saharan Africa due to infections and infestations. Contemporary studies from South Africa (6) and Nigeria (7) have built on historical reports to demonstrate that the aetiology and indeed case profile of acute HF (i.e. more women and younger individuals affected in the prime of their life) is different from high-income countries. As such, HF is now responsible for 7-10% of medical admissions in the region. (7) These are entirely based on studies on acute HF. There are only few data on chronic HF in Africa. Furthermore, the nexus between endemic infections such as tuberculosis (TB) and HIV/AIDS and other non-communicable or non-infectious risk factors and HF in Africa is scarcely documented.

Gaps in knowledge on heart failure in sub-Saharan Africa

  1. Co-morbidities in HF patients, which are common and important to outcomes, have not been well studied in large cohorts in sub-Saharan Africa (SSA).
  2. The role and co-occurrence of infection such as tuberculosis and HIV /AIDS has not been extensively explored in the region.

4 There is paucity of information on the long-term outcome of HF in SSA (rehospitalization and mortality) 5 Current phenotypes of HF (HFrEF, HFpEF, HFmrEF), their clinical and sociodemographic predictors, management and outcomes are not well described in SSA.

6 There is also paucity of data on the assessment of barriers to HF care in SSA.

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

入选标准

  • All cases of heart failure

排除标准

  • No consent to participate

结局指标

主要结局

Mortality

时间窗: 5 years

All cause mortality

次要结局

  • Hospitalisation(5 years)

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

研究点 (1)

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