HypertensionNCT05982847
National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa
An observational study of Hypertension and Obesity, Adolescent, run by North-West University, South Africa at 11 sites in 2 countries.
Trial summary
The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster relationships between the healthcare sector and schools through community engagement and outreach as well as contributing to the decolonization of normative paediatric blood pressure reference values. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Obesity, Adolescent, Obesity, Childhood
- What is being tested?
- Blood pressure screening
- How many people
- 22,464 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Apr 2024to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The target population for this study includes 5 to under 18 years school-aged children in South Africa from all provinces in the country selected in a randomized manner and to ensure generalizability. All South African public ordinary schools are categorised into five groups, called quintiles, largely for purposes of the allocation of financial resources from government. Quintile one is the lowest socioeconomic quintile, while quintile five is the highest. In addition, lower quintile schools are mostly rural and/or peri-urban. Participants will be drawn from quintile 1-5 schools and those in more remote areas will be reached via mobile fieldwork teams. A sample of 22 464 (81% Black African; 9% Coloured; 8% White and 2% Indian/Asian) will be required to enable computation of reference values for each age and sex across urban and rural settings in all provinces.
Who may be able to join
- All children between ages 5-<18 years
- All children with voluntary assent/consent and parent's permission
Who cannot join
- circumstances interfere with the participant's ability to give informed consent (diminished understanding or comprehension, or any language barriers that may pose potential risk in participation under false expectations)
- randomly selected children who choose not to participate (lack of assent/consent), even if parent's permission was received,
- conditions that interfere with a patient's ability to follow study guidelines, e.g., the use of drugs, alcohol or tobacco products
- ages >18 years or under 5 years
- Children will be excluded from the analysis for the determination of normative reference values for blood pressure and anthropometry if taking certain concomitant medication(s) that may affect their blood pressure, or any underlying disease e.g., chronic kidney disease, chronic heart disease etc. that may raise blood pressure.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
South Africa10 sites, 10 recruiting
- Recruiting
University of the Free State
Bloemfontein, Free State
Johannes Cronje, MD, rigel.jcc@gmail.com
- Not yet recruiting
Red Cross War Memorial Children Hospital
Cape Town, Western Cape
Peter Nourse, MD, peter.nourse@uct.ac.za
Mignon McCulloch, MD, mignon.mcculloch@uct.ac.za
- Not yet recruiting
South African Medical Research Council
Cape Town, Western Cape
Liesl Zuhlke, MD, liesl.zuhlke@mrc.ac.za
Rabia Johnson, PhD, rabia.johnson@mrc.ac.za
- Not yet recruiting
University of Cape Town
Cape Town, Western Cape
Sandra Mukasa, PhD, sandra.mukasa@uct.ac.za
Erika Jones, MD, erika.jones@uct.ac.za
- Not yet recruiting
University of KwaZulu-Natal
Durban, KwaZulu-Natal
Rajendra Bhimma, MD, bhimma@ukzn.ac.za
- Recruiting
University of the Witwatersrand
Johannesburg, Gauteng
Shane Norris, PhD, shane.norris@wits.ac.za
Lisa J Ware, PhD, lisa.ware@wits.ac.za
- Not yet recruiting
Walter Sisulu University
Mthatha, Eastern Cape
Benedicta Nkeh-Chungag, PhD, +27475021989, bnkehchungag@wsu.ac.za
- Not yet recruiting
University of Limpopo
Polokwane, Limpopo
Kotsedi D Monyeki, PhD, kotsedi.monyeki@ul.ac.za
- Recruiting
Nelson Mandela Metropolitan University
Port Elizabeth, Eastern Cape
Aayesha Kholvadia, PhD, Aayesha.Kholvadia@mandela.ac.za
Cheryl Walter, PhD, cheryl.walter@mandela.ac.za
- Recruiting
Hypertension in Africa Research Team (HART), North-West University
Potchefstroom, North West, 2531
Ruan Kruger, PhD, +27824902342 ext. 992904, Ruan.Kruger@nwu.ac.za
Lebo F Gafane-Matemane, PhD
Switzerland1 site, 1 recruiting
- Not yet recruiting
University of Zurich
Zurich
Friedrich Thienemann, MD, friedrich.thienemann@uct.ac.za
Friedrich Thienemann, MD
About this study
Official title: National Blood Pressure Screening in Children to Optimise Clinical Management of Paediatric Hypertension in South Africa
The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster relationships between the healthcare sector and schools through community engagement and outreach as well as contributing to the decolonization of normative paediatric blood pressure reference values. To date, there has been no nation-wide project in South Africa to determine nationally representative normal blood pressure reference values, nor to estimate the true prevalence of hypertension in the paediatric population of the country. This study will provide critical information on the understanding of blood pressure and hypertension in children, especially of African ancestry. Not only will this effort contribute to the development of the first nationally representative normal reference values of blood pressure but will also benefit healthcare providers in the sector with a clear guideline on the management of high blood pressure in children as developed by experts working with these challenges daily.
Read the detailed description
Rationale: Currently there exist no nationally representative set of normative reference values for blood pressure and anthropometry in South African children, while clinicians rely on European and US reference values. The latter seems inappropriate in the South African setting, especially considering the lack of data available in African ancestry normative data.
Objectives: The investigators aim to development the first nationally representative normal reference values of blood pressure and anthropometry in children, to develop scientific evidence-based hypertension guidelines in the paediatric population of South Africa.
Methods: The target population for this study includes 5 to under 18 years school-aged (all school quintiles) children in South Africa from all provinces in the country selected in a randomized manner and to ensure generalizability.
Population: A sample of 22 464 (81% Black African; 9% Coloured; 8% White and 2% Indian/Asian) will be required to enable computation of reference values for each age and sex across urban, peri-urban and rural settings in all provinces.
Time frame: The study will recruit and collect data over a period of five years.
Expected outcomes: The investigators expect that normative blood pressure in children (ages above 5 and under 18 years) will differ from currently accepted international thresholds. The investigators will engage in the communities to optimise awareness and care of high blood pressure and its comorbidities. Recommendations will be made to the National Department of Health regarding blood pressure measurement/screening for hypertension in children at the local clinic in the Road to Health booklet. The investigators will also develop the first clinical practice guidelines for the management of hypertension in children in South Africa in collaboration with hypertension societies.
- Conditions
- Hypertension, Obesity, Adolescent, Obesity, Childhood
- Being tested
- Blood pressure screening
- Keywords
- Adiposity, Blood Pressure, Cardiovascular Diseases, Health Knowledge, Attitudes, Practice, Lifestyle Factors
- Medical subject headings
- Hypertension, Pediatric Obesity, Obesity, Cardiovascular Diseases, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure screeningDiagnostic test
Also called Anthropometric measurements
Blood pressure and anthropometric measurements will be performed in children and adolescents between ages 5-18 years to develop South African nomograms that will aid in the development of clinical practice guidelines to optimise hypertension care in South Africa youth.
| Study group | Role | What they receive |
|---|---|---|
| Boys | Not described Receives: Diagnostic Test: Blood pressure screening | |
| Girls | Not described Receives: Diagnostic Test: Blood pressure screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine and compute nationally representative normative reference values for blood pressure in children
To date there are no national normative blood pressure reference values for children in South Africa. Normative values used by clinicians are those extrapolated from studies on blood pressure done in the USA and Europe and these may not be truly representative of normative values of blood pressure in South Africa. This study aims to address this issue, because children can be misdiagnosed for high blood pressure based on the wrong normative values.
Measured: Through study completion, an average of 1 year
To determine and compute nationally representative normative reference values for blood pressure in children
Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity only include a small sample size from less than five African countries, therefore the underrepresentation of children of African ancestry will be addressed by this study.
Measured: Through study completion, an average of 1 year
To develop clinical practice guidelines for the management of childhood hypertension in South Africa
The findings of this study will help develop clinically relevant guidelines for the management of hypertension in children between 5 and 18 years of age based on local normative values, as well as to improve cost and availability of anti-hypertensive agents for children and adolescents.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Apr 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22,464 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North-West University, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa, University of Cape Town, University of Limpopo, Walter Sisulu University, University of KwaZulu, Red Cross War Memorial Childrens Hospital, University of Witwatersrand, South Africa, University of Zurich, Groote Schuur Hospital, Nelson Mandela Metropolitan University, Chris Hani Baragwanath Academic Hospital, University of the Free State
- Responsible party
- Principal investigator, Ruan Kruger, North-West University, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982847
- Sponsor's protocol ID
- REC 4/23/03/22
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The national data will be first collated to develop the nomograms for blood pressure and anthropometric measurements. The data will be made available upon reasonable request from the principal investigator(s) after publication of the nomograms findings.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Blood Pressure Screening in Children to Optimise Clinical Management of Paediatric Hypertension in South Africa
- ClinicalTrials.gov ID
- NCT05982847
- Acronym / sponsor ID
- REC 4/23/03/22
- Conditions
- Hypertension, Obesity, Adolescent, Obesity, Childhood
- Keywords
- Adiposity, Blood Pressure, Cardiovascular Diseases, Health Knowledge, Attitudes, Practice, Lifestyle Factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 22,464 participants (estimated)
- Lead sponsor
- North-West University, South AfricaUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa, University of Cape Town, University of Limpopo, Walter Sisulu University, University of KwaZulu, Red Cross War Memorial Childrens Hospital, University of Witwatersrand, South Africa, University of Zurich, Groote Schuur Hospital, Nelson Mandela Metropolitan University, Chris Hani Baragwanath Academic Hospital, University of the Free State
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster relationships between the healthcare sector and schools through community engagement and outreach as well as contributing to the decolonization of normative paediatric blood pressure reference values. To date, there has been no nation-wide project in South Africa to determine nationally representative normal blood pressure reference values, nor to estimate the true prevalence of hypertension in the paediatric population of the country. This study will provide critical information on the understanding of blood pressure and hypertension in children, especially of African ancestry. Not only will this effort contribute to the development of the first nationally representative normal reference values of blood pressure but will also benefit healthcare providers in the sector with a clear guideline on the management of high blood pressure in children as developed by experts working with these challenges daily.
Detailed description
Rationale: Currently there exist no nationally representative set of normative reference values for blood pressure and anthropometry in South African children, while clinicians rely on European and US reference values. The latter seems inappropriate in the South African setting, especially considering the lack of data available in African ancestry normative data.
Objectives: The investigators aim to development the first nationally representative normal reference values of blood pressure and anthropometry in children, to develop scientific evidence-based hypertension guidelines in the paediatric population of South Africa.
Methods: The target population for this study includes 5 to under 18 years school-aged (all school quintiles) children in South Africa from all provinces in the country selected in a randomized manner and to ensure generalizability.
Population: A sample of 22 464 (81% Black African; 9% Coloured; 8% White and 2% Indian/Asian) will be required to enable computation of reference values for each age and sex across urban, peri-urban and rural settings in all provinces.
Time frame: The study will recruit and collect data over a period of five years.
Expected outcomes: The investigators expect that normative blood pressure in children (ages above 5 and under 18 years) will differ from currently accepted international thresholds. The investigators will engage in the communities to optimise awareness and care of high blood pressure and its comorbidities. Recommendations will be made to the National Department of Health regarding blood pressure measurement/screening for hypertension in children at the local clinic in the Road to Health booklet. The investigators will also develop the first clinical practice guidelines for the management of hypertension in children in South Africa in collaboration with hypertension societies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boys | – | Diagnostic Test: Blood pressure screening |
| Girls | – | Diagnostic Test: Blood pressure screening |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The target population for this study includes 5 to under 18 years school-aged children in South Africa from all provinces in the country selected in a randomized manner and to ensure generalizability. All South African public ordinary schools are categorised into five groups, called quintiles, largely for purposes of the allocation of financial resources from government. Quintile one is the lowest socioeconomic quintile, while quintile five is the highest. In addition, lower quintile schools are mostly rural and/or peri-urban. Participants will be drawn from quintile 1-5 schools and those in more remote areas will be reached via mobile fieldwork teams. A sample of 22 464 (81% Black African; 9% Coloured; 8% White and 2% Indian/Asian) will be required to enable computation of reference values for each age and sex across urban and rural settings in all provinces.
Key inclusion criteria (2 listed)
- All children between ages 5-<18 years
- All children with voluntary assent/consent and parent's permission
Key exclusion criteria (5 listed)
- circumstances interfere with the participant's ability to give informed consent (diminished understanding or comprehension, or any language barriers that may pose potential risk in participation under false expectations)
- randomly selected children who choose not to participate (lack of assent/consent), even if parent's permission was received,
- conditions that interfere with a patient's ability to follow study guidelines, e.g., the use of drugs, alcohol or tobacco products
- ages >18 years or under 5 years
- Children will be excluded from the analysis for the determination of normative reference values for blood pressure and anthropometry if taking certain concomitant medication(s) that may affect their blood pressure, or any underlying disease e.g., chronic kidney disease, chronic heart disease etc. that may raise blood pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure screeningAlso: Anthropometric measurementsBlood pressure and anthropometric measurements will be performed in children and adolescents between ages 5-18 years to develop South African nomograms that will aid in the development of clinical practice guidelines to optimise hypertension care in South Africa youth. | Diagnostic test | Boys, Girls |
Primary outcome
To determine and compute nationally representative normative reference values for blood pressure in children
Time frame: Through study completion, an average of 1 year
To date there are no national normative blood pressure reference values for children in South Africa. Normative values used by clinicians are those extrapolated from studies on blood pressure done in the USA and Europe and these may not be truly representative of normative values of blood pressure in South Africa. This study aims to address this issue, because children can be misdiagnosed for high blood pressure based on the wrong normative values.
To determine and compute nationally representative normative reference values for blood pressure in children
Time frame: Through study completion, an average of 1 year
Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity only include a small sample size from less than five African countries, therefore the underrepresentation of children of African ancestry will be addressed by this study.
To develop clinical practice guidelines for the management of childhood hypertension in South Africa
Time frame: Through study completion, an average of 1 year
The findings of this study will help develop clinically relevant guidelines for the management of hypertension in children between 5 and 18 years of age based on local normative values, as well as to improve cost and availability of anti-hypertensive agents for children and adolescents.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Undecided. The national data will be first collated to develop the nomograms for blood pressure and anthropometric measurements. The data will be made available upon reasonable request from the principal investigator(s) after publication of the nomograms findings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Obesity, Adolescent, run by North-West University, South Africa at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Africa, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruan Kruger, PhD (+27182992904, ruan.kruger@nwu.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine and compute nationally representative normative reference values for blood pressure in children (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.