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Trial record 1 of 1 for:    NCT03292094
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The African-PREDICT Study (PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03292094
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : September 10, 2020
Sponsor:
Collaborators:
South African Medical Research Council, SAMRC
National Research Foundation of South Africa
GlaxoSmithKline
Medical Research Council
Pfizer
Boehringer Ingelheim
Novartis
Mediclinic Hospital
Roche Diagnostics
Information provided by (Responsible Party):
Alta Schutte, North-West University, South Africa

Tracking Information
First Submitted Date September 12, 2017
First Posted Date September 25, 2017
Last Update Posted Date September 10, 2020
Actual Study Start Date February 4, 2013
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2017)
Incident Hypertension [ Time Frame: 5 years ]
Incident hypertension based on 4 repeated clinic blood pressure measurements, i.e. SBP>=140 mmHg and/or DBP >=90 mmHg.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The African-PREDICT Study
Official Title African Prospective Study for the Early Detection and Identification of Cardiovascular Disease and Hypertension (African-PREDICT Study)
Brief 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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Biological samples for biomarker analyses (serum, plasma, spot urine and 24-hr urine) were taken at baseline and each follow-up. Samples are preserved for the short and long-term at -80°C. We will assess a wide range of traditional and novel biomarkers related to hypertension and cardiovascular disease. 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
Sampling Method Non-Probability Sample
Study Population Apparently healthy black and white participants between the ages of 20 and 30 years from the Potchefstroom area, North West Province, South Africa.
Condition
  • Cardiovascular Diseases
  • Hypertension
  • Health Risk Behaviors
  • Arterial Stiffness
  • Young
  • Renin Hypertension
Intervention Not Provided
Study Groups/Cohorts
  • Black men
    294 young healthy men were included (clinic normotensive, non-HIV)
  • White men
    284 young healthy men were included (clinic normotensive, non-HIV)
  • Black women
    312 young healthy women were included (clinic normotensive, non-HIV)
  • White women
    312 young healthy women were included (clinic normotensive, non-HIV)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 7, 2018)
1202
Original Estimated Enrollment
 (submitted: September 22, 2017)
1200
Estimated Study Completion Date December 3, 2027
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Brachial BP <140 and 90 mmHg
  • HIV uninfected
  • No previous diagnosis or medication for chronic disease
  • Not pregnant or breastfeeding

Exclusion Criteria:

  • Planning to move away from the Potchefstroom area in the next 5 years
  • Currently pregnant or breastfeeding
  • Sick on the day of appointment
  • Lack the ability to read or understand English
  • Diagnosed with HIV, Cancer, Tuberculosis, Diabetes, Hypertension, Liver or Kidney disease, Heart disease
  • Previously had a heart attack or stroke
  • Have suffered a recent trauma or had surgery in the past 3 months
  • Have a phobia for needles
  • Have donated blood in the previous 3 months
  • Taking chronic medication (Anti-inflammatory, for Hypertension of Diabetes, Cortisone, Anti-Retroviral, Thyroid medication, Cholesterol medication)
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 30 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries South Africa
Removed Location Countries  
 
Administrative Information
NCT Number NCT03292094
Other Study ID Numbers NWU-00001-12-A1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Alta Schutte, North-West University, South Africa
Study Sponsor North-West University, South Africa
Collaborators
  • South African Medical Research Council, SAMRC
  • National Research Foundation of South Africa
  • GlaxoSmithKline
  • Medical Research Council
  • Pfizer
  • Boehringer Ingelheim
  • Novartis
  • Mediclinic Hospital
  • Roche Diagnostics
Investigators
Principal Investigator: Alta Schutte, PhD University of New South Wales
Principal Investigator: Carina MC Mels, PhD North-West University
PRS Account North-West University, South Africa
Verification Date September 2020