Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05936164 |
| Other study ID # |
NigAfibRegistry_V.2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2023 |
| Est. completion date |
December 31, 2028 |
Study information
| Verified date |
June 2023 |
| Source |
University College Hospital, Ibadan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
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.
Description:
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.
Research Questions
1. What are the hospital and community prevalence of AF in Nigeria.
2. What are the clinical features and modes of presentation of AF in Nigeria?
3. What are the risk factors of AF in Nigeria?
4. What are the complications of AF in Nigeria?
5. What are the modes of management of AF in Nigeria?
6. What are the 12-months outcomes of AF in the country and are there predictive models of
outcome in the country? Brief Literature Review Globally it is estimated that there 2.7
million new cases in males and 2.0 million cases in females of AF. (1) The age adjusted
mortality rate 1.6 and 1.7 for men and women respectively of AF has been reported. In
terms of disability adjusted life years (DALYs), this is estimated as 64.5 and 45.9 per
100,000 populations for men and women respectively. (1) AF is associated with increased
risk of mortality after adjusting for other confounders. In the Framingham Heart Study,
AF was associated with 1.5-1.9-fold increase in mortality in over 40-years of follow-up.
In the Olmsted County Study, the mortality associated with AF at 4- and 12- months was
17 and 23% respectively. Elderly individuals (aged 70 years and above in rural Tanzania
have 1-year mortality of 50% and 66.6% in men and women respectively AF has significant
impact on healthcare cost. The major drivers of the cost are hospitalisations, stroke
and loss of productivity (3) Globally AF accounts for less than 1% of all deaths.
However, because it co-exist 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. (3) There is limited data on population/ hospital
prevalence and incidence of AF in SSA in general and Nigeria (Africa's most populous
nation in particular) The very few hospitals based data are from Cameroon, Ivory Coast,
Kenya, Senegal and South Africa. Most were retrospective report. The few from Nigeria
recruited very few subjects (less than 100) (4) In South Africa about 4.6% of patients
seen in a cardiac clinic had AF giving a prevalence of 5.6/100,000 population per year.
(16) The estimated prevalence in Ivory Coast is 5.5/100,000 population based on a
retrospective review over a 10-year period. AF prevalence in Senegal was estimated as
5.4% and it accounted for 66% of all heart rhythm disorders in the country. About 162
patients out of 22,144 medical patients were reported to have AF /Flutter in a private
tertiary hospital in Kenya giving a prevalence of 0.7%.
In a community-based study in Tanzania, the crude prevalence of AF was low (0.7%). This is
lower than similar study in Europe and North America where the prevalence is about 10% (in
those aged 80 years and above) and 5% in those aged 65 years and above respectively.
The prevalence of AF among Africa Americans is strikingly lower compared to their Caucasian
counterpart even when the risk factors for AF are higher in the former.
Research Methodology Design The study shall be prospective, observational and shall be
conducted in 6 hospitals in the six geopolitical regions of the country. The community survey
shall be cross-sectional in randomly selected urban and rural areas in the six geopolitical
regions in the country Study population Subjects are eligible to participate if they are 18
years and above and have 12-lead ECG features of AF.
Exclusion criteria Subjects who refuse to participate in the study and pregnant women.
Consent Written and/or informed consent shall be obtained from the subjects prior to
enrolment into the study.
Enrollment and data collection All subjects with clinical diagnosis of AF shall be recruited.
Data from each subject shall be obtained using a uniform and standardized case report forms
and a detailed clinical documentation on newly diagnosed/ newly presenting cases/
pre-existing cases of HF shall be carried out. The following data shall be obtained: study
identification number, centre code, demographic data, date of diagnosis of HF and
pre-admission history (previous heart failure related admissions). Others include NYHA
functional class, symptoms, signs, self-reported cardiovascular risk factors, aetiological
risk factors/ co-morbidities, blood investigations, 12-lead ECG, echocardiography,
medications and 12-month outcome.
Follow up Follow-up of subjects shall be through clinic visits or via telephone (if patient
can't come to the clinic). Telephone numbers of next of kin of patients shall also be
obtained. The follow up period shall be at one month, six month and 12 months from the time
of consent. This will be conducted through the use of research nurses. Information that shall
be obtained during the follow-up period includes well-being of the patient, symptoms, signs,
medications as well as outcome.
Data analysis Data shall be entered by experienced personnel on personal computers and
analyzed with SPSS version 11.0 (SPSS, Inc. Chicago Illinois) Other statistical packages such
as STATA and SAS shall be used where necessary. Descriptive statistics for baseline data will
be performed on continuous variables using mean, standard deviation, range and median where
appropriate. Categorical variables shall be expressed as percentages. McNemar and chi-square
tests (for categorical variables) and Student's t-test or analysis of variance (for
continuous variables) shall be used for comparisons as appropriate. Advanced statistical
analysis e.g. regression analysis shall be applied as necessary.
Data dissemination plan Publication policy will be decided by a writing committee consisting
of all the members of the steering committee and the principal investigators from all
participating sites. However, all the members of the steering committee, all principal
investigators and all those considered by the steering committee to have contributed
sufficiently to the study will be co-authors of the primary publications.
Expected Results The project will provide information on: i. 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.
