Hypertension Clinical Trial
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.
Status | Recruiting |
Enrollment | 22464 |
Est. completion date | November 30, 2028 |
Est. primary completion date | November 30, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | Inclusion Criteria: - All children between ages 5-<18 years - All children with voluntary assent/consent and parent's permission Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
South Africa | University of the Free State | Bloemfontein | Free State |
South Africa | Red Cross War Memorial Children Hospital | Cape Town | Western Cape |
South Africa | South African Medical Research Council | Cape Town | Western Cape |
South Africa | University of Cape Town | Cape Town | Western Cape |
South Africa | University of KwaZulu-Natal | Durban | KwaZulu-Natal |
South Africa | University of the Witwatersrand | Johannesburg | Gauteng |
South Africa | Walter Sisulu University | Mthatha | Eastern Cape |
South Africa | University of Limpopo | Polokwane | Limpopo |
South Africa | Nelson Mandela Metropolitan University | Port Elizabeth | Eastern Cape |
South Africa | Hypertension in Africa Research Team (HART), North-West University | Potchefstroom | North West |
Switzerland | University of Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
North-West University, South Africa | Chris Hani Baragwanath Academic Hospital, Groote Schuur Hospital, Medical Research Council, South Africa, Nelson Mandela Metropolitan University, Red Cross War Memorial Childrens Hospital, University of Cape Town, University of KwaZulu, University of Limpopo, University of the Free State, University of Witwatersrand, South Africa, University of Zurich, Walter Sisulu University |
South Africa, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through study completion, an average of 1 year | |
Primary | 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. | Through study completion, an average of 1 year | |
Primary | 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. | Through study completion, an average of 1 year |
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