NCT03292094

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,202

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2013Dec 2027

Study Start

First participant enrolled

February 4, 2013

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2027

Expected
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

4.8 years

First QC Date

September 12, 2017

Last Update Submit

April 24, 2024

Conditions

Cardiovascular DiseasesHypertensionHealth Risk BehaviorsArterial StiffnessYoungRenin Hypertension

Keywords

YoungHealthyAfricanLongitudinalHypertensionSalt intakeObesityOrgan damage

Outcome Measures

Primary Outcomes (1)

  • Incident Hypertension

    Incident hypertension based on 4 repeated clinic blood pressure measurements, i.e. SBP\>=140 mmHg and/or DBP \>=90 mmHg.

    5 years

Study Arms (4)

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)

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension Research and Training Clinic

Potchefstroom, North West, 2531, South Africa

Location

Related Publications (6)

  • Mokgonyana PJ, Mokwatsi GG, Gwini SM, Gafane-Matemane LF. The relationship between kidney function and the soluble (pro)renin receptor in young adults: the African-PREDICT study. BMC Nephrol. 2025 Apr 3;26(1):172. doi: 10.1186/s12882-025-04038-x.

    PMID: 40181300DERIVED

  • Degenaar A, Kruger R, Jacobs A, Mels CMC. Phenotyping Kidney Function in Young Adults With High Blood Pressure: The African-PREDICT Study. J Clin Hypertens (Greenwich). 2024 Nov;26(11):1291-1300. doi: 10.1111/jch.14911. Epub 2024 Oct 5.

    PMID: 39368068DERIVED

  • Strauss-Kruger M, Pieters M, van Zyl T, Gafane-Matemane LF, Mokwatsi GG, Jacobs A, Schutte AE, Louw R, Mels CM. Metabolomic Insights on Potassium Excretion, Blood Pressure, and Glucose Homeostasis: The African-PREDICT Study. J Nutr. 2024 Feb;154(2):435-445. doi: 10.1016/j.tjnut.2023.12.025. Epub 2023 Dec 16.

    PMID: 38110181DERIVED

  • Gafane-Matemane LF, Kruger R, Smith W, Mels CMC, Van Rooyen JM, Mokwatsi GG, Uys AS, Brits SJ, Schutte AE. Characterization of the Renin-Angiotensin-Aldosterone System in Young Healthy Black Adults: The African Prospective Study on the Early Detection and Identification of Hypertension and Cardiovascular Disease (African-PREDICT Study). Hypertension. 2021 Aug;78(2):400-410. doi: 10.1161/HYPERTENSIONAHA.120.16879. Epub 2021 Jun 28.

    PMID: 34176281DERIVED

  • Kochli S, Schutte AE, Botha-Le Roux S, Gafane-Matemane LF, Smith W, van Rooyen JM, Mokwatsi GG, Kruger R. Potassium excretion and blood pressure are associated with heart rate variability in healthy black adults: The African-PREDICT study. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1071-1080. doi: 10.1016/j.numecd.2020.12.021. Epub 2020 Dec 24.

    PMID: 33549447DERIVED

  • Crouch SH, Botha-Le Roux S, Delles C, Graham LA, Schutte AE. Inflammation and hypertension development: A longitudinal analysis of the African-PREDICT study. Int J Cardiol Hypertens. 2020 Dec;7:100067. doi: 10.1016/j.ijchy.2020.100067.

    PMID: 33392493DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionHealth Risk BehaviorsObesity

Condition Hierarchy (Ancestors)

Vascular DiseasesHealth BehaviorBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alta Schutte, PhD

    University of New South Wales

    PRINCIPAL INVESTIGATOR

  • Carina MC Mels, PhD

    North-West University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 25, 2017

Study Start

February 4, 2013

Primary Completion

November 30, 2017

Study Completion (Estimated)

December 3, 2027

Last Updated

April 25, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)