White Coat HypertensionWCHNCT05919420
White-coat Hypertension in Childhood - Effects on Blood Pressure and Organ Damage
An observational study of White Coat Hypertension, run by Karolinska Institutet.
Trial summary
White coat hypertension, WCH means that the blood pressure are above normal values only when measured at visits to the doctor, but not at home. WCH has in adults proved to be predisposing to the development of hypertension, and damage to the heart and arteries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- White Coat Hypertension
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 56 participants with WCH that were identified in a previous study
Who may be able to join
- being identified in our previous study as having WCH
Who cannot join
- none
About this study
White coat hypertension, WCH means that the blood pressure are above normal values only when measured at visits to the doctor, but not at home. WCH has in adults proved to be predisposing to the development of hypertension, and damage to the heart and arteries. It is not known if children and young people run the same risk as adults with WCH.
The investigators have previously examined the blood pressure of 1473 healthy children and adolescents in the study "Screening for high blood pressure and silent kidney disease in school children" and the results were published recently in the American Journal of Hypertension. In the study, we identified a number of participants who had the WCH.
Read more
The investigators are implementing now, 10 years later, a follow-up study to investigate if these children with WCH have an increased risk of hypertension and subsequent cardiovascular disease. The goal is to investigate whether these young individuals are at similar risk as adults with WCH for hypertension and impaired cardiovascular function.
The investigators will provide our WCH participants extended examinations of the heart, blood vessels and kidney function, which will provide important information as to whether there are effects on cardiovascular health already in adolescence among participants that suffered from WCH in childhood. This is important knowledge in clinical work in order to learn how to best care for these children to minimize their risk of future disease.
Read the detailed description
This is a longitudinal study in which all patients with WCH who previously participated in the above-mentioned study are included. The PI will offer the participants an outpatient check-up, which means:
- measurement of blood pressure with ambulatory blood pressure measurement during 24 hours to study blood pressure level and variation in blood pressure during the day.
- ultrasound examination of the structure and function of the heart
- ultrasound examination of blood vessels for calculation of intima-media thickness
- investigation of vessel elasticity with pulse wave analysis with Arteriograph.
- analysis of blood and urine to examine kidney function.
- Questionnaire about eating habits and physical activity
These examinations will be carried out at the Physiology Clinic, Karolinska University Hospital, Huddinge. Both ultrasound examination of blood vessels and pulse wave velocity are non-invasive examinations and provide important information about the patient's vascular status. We will take a venous blood sample (approx. 5 ml) for analysis of standard markers for organ damage and vascular function (creatinine, urate, urea, cystatin C) and a urine sample (urine albumin/creatinine). These standard measurements and sampling involve a minimal impact on the individual and the subsequent analysis methods are well developed and have been applied in several previous studies. We will also ask questions about lifestyle, which is part of the doctor's medical history. In cases where hypertension, with or without organ damage, is verified, the persons will be referred further to pediatric nephrology or to adult medicine.
The sampling is recorded according to usual routines and the participation in the study is also indicated.
Each participant is assigned a code number. Some patient-related clinical data will be recorded, such as body measurements and analysis results from blood sampling. Questionnaire responses and results from examinations from cardiac echocardiography, vascular doppler and pulse wave velocity are coded. The code list is kept separately in a locked space. Participating researchers all have access to the code list. During data processing, only coded information is used.
- Conditions
- White Coat Hypertension
- Medical subject headings
- White Coat Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension
blood pressure at hypertensive level
Measured: at follow up (average 9,3 years after baseline)
Left ventricular hypertrophy
echocardiographic measurment
Measured: at follow up (average 9,3 years after baseline)
vascular elasticity
pulse wave velocity
Measured: at follow up (average 9,3 years after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study startSep 2015
- Primary completion1 Dec 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Coat HypertensionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael T Krmar, MD PhD, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05919420
- Sponsor's protocol ID
- WCH
- Acronym
- WCH
- Status last verified
- Jun 2023
- First submitted
- 9 Dec 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White-coat Hypertension in Childhood - Effects on Blood Pressure and Organ Damage
- ClinicalTrials.gov ID
- NCT05919420
- Acronym / sponsor ID
- WCH / WCH
- Conditions
- White Coat Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 26 Jun 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.
White coat hypertension, WCH means that the blood pressure are above normal values only when measured at visits to the doctor, but not at home. WCH has in adults proved to be predisposing to the development of hypertension, and damage to the heart and arteries. It is not known if children and young people run the same risk as adults with WCH.
The investigators have previously examined the blood pressure of 1473 healthy children and adolescents in the study "Screening for high blood pressure and silent kidney disease in school children" and the results were published recently in the American Journal of Hypertension. In the study, we identified a number of participants who had the WCH.
The investigators are implementing now, 10 years later, a follow-up study to investigate if these children with WCH have an increased risk of hypertension and subsequent cardiovascular disease. The goal is to investigate whether these young individuals are at similar risk as adults with WCH for hypertension and impaired cardiovascular function.
The investigators will provide our WCH participants extended examinations of the heart, blood vessels and kidney function, which will provide important information as to whether there are effects on cardiovascular health already in adolescence among participants that suffered from WCH in childhood. This is important knowledge in clinical work in order to learn how to best care for these children to minimize their risk of future disease.
Detailed description
This is a longitudinal study in which all patients with WCH who previously participated in the above-mentioned study are included. The PI will offer the participants an outpatient check-up, which means:
- measurement of blood pressure with ambulatory blood pressure measurement during 24 hours to study blood pressure level and variation in blood pressure during the day.
- ultrasound examination of the structure and function of the heart
- ultrasound examination of blood vessels for calculation of intima-media thickness
- investigation of vessel elasticity with pulse wave analysis with Arteriograph.
- analysis of blood and urine to examine kidney function.
- Questionnaire about eating habits and physical activity
These examinations will be carried out at the Physiology Clinic, Karolinska University Hospital, Huddinge. Both ultrasound examination of blood vessels and pulse wave velocity are non-invasive examinations and provide important information about the patient's vascular status. We will take a venous blood sample (approx. 5 ml) for analysis of standard markers for organ damage and vascular function (creatinine, urate, urea, cystatin C) and a urine sample (urine albumin/creatinine). These standard measurements and sampling involve a minimal impact on the individual and the subsequent analysis methods are well developed and have been applied in several previous studies. We will also ask questions about lifestyle, which is part of the doctor's medical history. In cases where hypertension, with or without organ damage, is verified, the persons will be referred further to pediatric nephrology or to adult medicine.
The sampling is recorded according to usual routines and the participation in the study is also indicated.
Each participant is assigned a code number. Some patient-related clinical data will be recorded, such as body measurements and analysis results from blood sampling. Questionnaire responses and results from examinations from cardiac echocardiography, vascular doppler and pulse wave velocity are coded. The code list is kept separately in a locked space. Participating researchers all have access to the code list. During data processing, only coded information is used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 56 participants with WCH that were identified in a previous study
Key inclusion criteria (1 listed)
- being identified in our previous study as having WCH
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypertension
Time frame: at follow up (average 9,3 years after baseline)
blood pressure at hypertensive level
Left ventricular hypertrophy
Time frame: at follow up (average 9,3 years after baseline)
echocardiographic measurment
vascular elasticity
Time frame: at follow up (average 9,3 years after baseline)
pulse wave velocity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of White Coat Hypertension, run by Karolinska Institutet.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension (time frame: at follow up (average 9,3 years after baseline)). 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 19 Sep 2024.