Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03292094 |
Other study ID # |
NWU-00001-12-A1 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 4, 2013 |
Est. completion date |
December 3, 2027 |
Study information
Verified date |
April 2024 |
Source |
North-West University, South Africa |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The African-PREDICT study aims to (i) generate new knowledge on the early pathophysiology
accompanying hypertension development in black South Africans; and (ii) to identify early
novel markers or predictors for the development of hypertension and cardiovascular outcome.
By employing also in Africa the latest cutting-edge scientific technologies to measure single
and multiple biomarkers proven to predict hypertension and cardiovascular outcome (such as
multiplex analyses, proteomics and metabolomics), precision medicine may have the potential
to lead to novel strategies in preventing and treating hypertension in Africa.
Description:
Background and Problem Statement: Recent global analyses have indicated that the highest
blood pressures worldwide are recorded in black populations. The vulnerable cardiovascular
profile of Africans is believed to result from a combination of factors such as rapid
urbanisation, abnormal sodium handling, elevated vascular resistance and arterial stiffness.
The frequent underdiagnoses and ineffective treatment of hypertension in general but
especially in Africans, result in severe complications, such as stroke, heart and kidney
disease. Since diagnosis and treatment are generally unsuccessful in black populations -
especially in low and middle-income countries - prevention is key to curb the rapidly
increasing incidence of death and disability from cardiovascular disease. Cardiovascular risk
prediction in black populations worldwide is inadequate since we do not have a clear
understanding of the complex mechanisms underlying the development of cardiovascular disease.
Main Aim: In the "African PRospective study on the Early Detection and Identification of
Cardiovascular disease and Hypertension" (African-PREDICT) the investigators aim to identify
early markers or predictors for the development of cardiovascular disease in black South
Africans. Only by understanding the early pathophysiology of disease development, and by
identifying markers as potential screening indicators, predictors or targets for
intervention, will the investigators be able to implement successful prevention programes in
Africans at younger ages. The researchers therefore aim to track and monitor change in young,
normotensive black and white individuals (aged 20-30 years) over 10-20 years. To achieve this
the investigators will perform detailed cardiovascular and novel biomarker measurements, as
well as behavioural and biopsychosocial assessments every 4-5 years in order to identify and
understand early changes in cardiovascular function, and specific predictors contributing to
the development of hypertension and target organ damage.
Methodology and Measurements: In 2013 recruitment started, screening and assessment of 1200
normotensive and apparently healthy participants (black N=600 and white N=600) with equal sex
distribution. A wide range of basic and advanced measurements are taken within a Hypertension
Clinic to get a highly detailed profile of the participants at each visit. The following is
obtained: (1) relevant questionnaire data including medical history, lifestyle, social
status, traditional risk factors (age, gender, smoking, alcohol intake) and validated
questionnaires on dietary intake, personality and psychosocial profile; (2) Biological
samples for biomarker analyses (serum, plasma, spot urine and 24-hr urine) are taken and
preserved for the short and long-term at -80°C. A wide range of traditional and novel
biomarkers related to hypertension and cardiovascular disease (including amongst others,
lipid profile, glucose, glycated hemoglobin, C-reactive protein, interleukin-6, vitamin D,
full blood count, sodium, potassium, creatinine, renin, aldosterone, angiotensin II, markers
of oxidative stress and nitric oxide bio-availability, cortisol, sex hormones, insulin,
C-peptide, leptin and other adipokines, angiogenic markers, the insulin-like growth
factor-axis, soluble urokinase plasminogen activator receptor, Nt-proBNP, fibulin-1 and novel
markers not yet identified) will be assessed. These samples will also be analysed in an
attempt to identify bio-signatures in terms of the -omics sciences (genomic, metabolomic and
proteomic profiles) as predictors of cardiovascular deterioration; (3) anthropometric
measurements, bio-electrical impedance measurement of body fat and lean mass, and 7-day
physical activitymonitoring; (4) A range of cardiovascular assessments: 24-hour blood
pressure, central arterial pressure, and cardiovascular stress reactivity tests with
continuous finger blood pressure; and (5) Assessments of early target organ damage including
urinary albumin-to-creatinine ratio, carotid intima-media thickness, ECG, echocardiography,
pulse wave velocity, and retinal microvascular calibre and dilation during provocation with a
light flicker test.
Timetable: The project was approved and is endorsed by the National and Provincial Department
of Health, and was approved by the Ethics Committee of the North-West University in 2012
(NWU-00001-12-A1). Screening commenced in November 2012, and research participants started
entering the study from 6 February 2013. Baseline data collection was completed in December
2017. Follow-up assessments commenced in February 2018 and will continue until Dec 2022. The
Health Research Ethics Committee approved continuation of the study for 2020.
Anticipated Outcomes: This project will increase understanding of the complex mechanisms
involved in the aetiology of early cardiovascular changes in relatively young individuals
from African and European ancestry, which will (1) improve ability to identify individuals at
risk before the development of cardiovascular diseases (CVD), and (2) predict the development
of future hypertension and related CVD. Both outcomes will make it possible to develop better
individualised and population-based prevention of CVD contributing to better quality of life.
These results will not only be applicable to Sub-Saharan Africa but are expected to have a
broader impact with regards to white and black populations globally. Results are expected to
have significant scientific impact by means of publications in high-impact journals; and also
to translate directly into novel preventive healthcare policy and practices - translating
into preventive measures regarding the development of CVDs in clinics throughout South
Africa.