Down SyndromeNCT04735874
Vascular Health and Risk Factors in Children With Down Syndrome
An observational study of Down Syndrome and Cardiovascular Risk Factor, run by University of Utah at 1 site in United States.
Trial summary
This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with Down Syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Cardiovascular Risk Factor, Atherosclerosis
- What is being tested?
- Evaluate vascular disease risk factors in children with Down Syndrome and Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2021to 30 Jun 2023
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All children with DS (10.0-18.0 years of age) will be eligible, including those with translocations and mosaicism
Who may be able to join
- All children with Down Syndrome (10.0-18.0 years of age)
- Children with translocations and mosaicism
- Children with and without CHD
Who cannot join
- Patients with a history of hypoplastic arch, coarctation or catheter or surgical based aorta interventions
- Patients who are currently treated or have been treated with chemotherapy for cancer or a myeloproliferative disorder within 1 year of the study
- Participants whose parent/legally authorized representative (LAR) perceives the child is not able to cooperate with vascular imaging studies
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with Down Syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis.
- Conditions
- Down Syndrome, Cardiovascular Risk Factor, Atherosclerosis
- Being tested
- Evaluate vascular disease risk factors in children with Down Syndrome, Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome
- Keywords
- Down Syndrome, Cardiovascular Risk Factor, Atherosclerosis
- Medical subject headings
- Down Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluate vascular disease risk factors in children with Down SyndromeOther
We will determine CV disease risk profiles in children with DS at our centers. We will compare these data to published national norms of children without DS. Risk factor data will include: anthropometric measures; blood pressure; history of congenital heart disease and associated surgery, sleep apnea, hypothyroidism, and cancer; fasting blood draw [lipid panel with subfractions (NMR), insulin, glucose, and CRP].
Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down SyndromeOther
We will perform PWV, CIMT, and CD studies in children with DS and compare these data to available data in children without DS. We will also perform multivariable analysis of the influence of combinations of CV disease risk factors on markers of early atherosclerosis in children with DS. Hypothesis: CV disease risk factors will correlate with markers of early atherosclerosis in children with DS but the associations between risk factors and markers of early atherosclerosis will differ between children with DS vs. the general population of children.
| Study group | Role | What they receive |
|---|---|---|
| Children ages 10.0 to 18.0 | Not described Receives: Other: Evaluate vascular disease risk factors in children with Down Syndrome; Other: Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mean pulse wave velocity between children with Down syndrome and published national data in children without Down syndrome at one time point.
Pulse wave velocity (PWV) is a non-invasive imaging measure of arterial stiffness. Pulse wave velocity measures vascular stiffness by evaluating the time for a pressure wave to travel through the aorta. The velocity is determined by the elasticity and geometry of the vessel. PWV will be measured using a SphygmoCor device. With the participant in the supine position and ECG leads attached, the maximal pulsation of the right carotid and right femoral artery will be marked and measured from the suprasternal notch using a tape measure (carotid) and caliper (femoral). A tonometer will record the carotid and femoral impulses. The device calculates PWV as the difference in the carotid-to-distal path length divided by the difference in R-wave-to-waveform times (∆distance/∆time, m/sec). Measurements will be in triplicate and averaged. PWV can be completed in ~30 mins.
Measured: One day patient visit
Secondary outcomes (7)
The difference in mean carotid intimal medial thickness between children with Down syndrome and published national data in children without Down syndrome measured at 1 time point.
Carotid intimal medial thickness (CIMT) is a non-invasive imaging measure of carotid artery thickness. B-mode ultrasound with a high-resolution linear array vascular transducer will be used to record common, bulb, and internal CIMT.
Measured: One day patient visit
Correlation of body mass index (BMI) anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Height (centimeters) will be measured using standard stadiometers and weight (kilograms) using a calibrated scale available at each site. BMI (kg/m2) will be calculated and converted to age- and sex-matched Down Syndrome percentiles. Measured at 1 time point.
Measured: One day patient visit
Correlation of waist circumference anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Waist circumference will be measured at the top of the posterior iliac crest (NHANES standard) and normalized by calculating waist to height ratio. Measured at 1 time point.
Measured: One day patient visit
Correlation of serologic cardiovascular risk factors include fasting lipid panel on PWV and CIMT in children with Down syndrome.
A fasting lipid profile will be obtained to measure total cholesterol, triglycerides, and HDL cholesterol. Trained pediatric phlebotomists will perform the blood draw after the participant has fasted ≥10 hours. A standard lipid profile will provide total cholesterol, HDL cholesterol, and triglycerides. LDL will be calculated using the Friedwald equation when triglycerides are <400 mg/dL. For triglycerides ≥400 mg/dl, LDL will be measured directly via a homogeneous enzymatic assay. Measured at 1 time point.
Measured: One day patient visit
Correlation of serologic cardiovascular risk factors include lipoprotein on PWV and CIMT in children with Down syndrome.
Lipoprotein subfractions by NMR will be used to describe lipid particle number and size. These lipoprotein measurements likely estimate CV risk more accurately than a standard lipid profile alone. Lipoprotein sub-fractionation will be completed using proton NMR signals. Measured at 1 time point.
Measured: One day patient visit
Correlation of serologic cardiovascular risk factors include insulin resistance on PWV and CIMT in children with Down syndrome.
Insulin resistance will be assessed by fasting serum glucose, hemoglobin A1C, and insulin level since diabetes (fasting glucose ≥126 mg/dL or hemoglobin A1C ≥6.5%) is a major risk factor. Measured at 1 time point.
Measured: One day patient visit
Correlation of clinical cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
A detailed personal history for congenital heart disease (CHD) and associated surgery, sleep apnea, hypothyroidism, and cancer will be obtained as all are common in the population with Down Syndrome and increase the risk for cardiovascular disease in adulthood. The fundamental CHD and associated surgery will be obtained from the medical records. The parent/LAR will be questioned and the medical record reviewed for a history of sleep apnea, hypothyroidism, and cancer (yes/no). Measured at 1 time point.
Measured: One day patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start2 Feb 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, The Hospital for Sick Children
- Responsible party
- Principal investigator, Adam Ware, University of Utah
- Investigators
- Adam L Ware, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735874
- Sponsor's protocol ID
- 00127761
- Status last verified
- Aug 2023
- First submitted
- 12 Nov 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ware AL, Miller DV, Porter CB, Edwards WD. Characterization of atrial morphology and sinus node morphology in heterotaxy syndrome: an autopsy-based study of 41 cases (1950-2008). Cardiovasc Pathol. 2012 Sep-Oct;21(5):421-7. doi: 10.1016/j.carpath.2011.12.007. Epub 2012 Jan 28.
PubMed 22285192Ware AL, Miller DV, Erickson LK, Menon SC. Marfan syndrome associated aortic disease in neonates and children: a clinical-morphologic review. Cardiovasc Pathol. 2016 Sep-Oct;25(5):418-22. doi: 10.1016/j.carpath.2016.06.002. Epub 2016 Jun 16.
PubMed 27479044Ware AL, Malmberg E, Delgado JC, Hammond ME, Miller DV, Stehlik J, Kfoury A, Revelo MP, Eckhauser A, Everitt MD. The use of circulating donor specific antibody to predict biopsy diagnosis of antibody-mediated rejection and to provide prognostic value after heart transplantation in children. J Heart Lung Transplant. 2016 Feb;35(2):179-85. doi: 10.1016/j.healun.2015.10.006. Epub 2015 Oct 8.
PubMed 26520246Ware AL, Tani LY, Weng HY, Wilkes J, Menon SC. Resource utilization and outcomes of infective endocarditis in children. J Pediatr. 2014 Oct;165(4):807-12.e1. doi: 10.1016/j.jpeds.2014.06.026. Epub 2014 Jul 23.
PubMed 25064162Ware AL, Young PC, Weng C, Presson AP, Minich LL, Menon SC. Prevalence of Coronary Artery Disease Risk Factors and Metabolic Syndrome in Children with Heart Disease. Pediatr Cardiol. 2018 Feb;39(2):261-267. doi: 10.1007/s00246-017-1750-2. Epub 2017 Oct 23.
PubMed 29058030Glasson EJ, Sullivan SG, Hussain R, Petterson BA, Montgomery PD, Bittles AH. The changing survival profile of people with Down's syndrome: implications for genetic counselling. Clin Genet. 2002 Nov;62(5):390-3. doi: 10.1034/j.1399-0004.2002.620506.x.
PubMed 12431254Head E, Phelan MJ, Doran E, Kim RC, Poon WW, Schmitt FA, Lott IT. Cerebrovascular pathology in Down syndrome and Alzheimer disease. Acta Neuropathol Commun. 2017 Dec 1;5(1):93. doi: 10.1186/s40478-017-0499-4.
PubMed 29195510Wilcock DM, Schmitt FA, Head E. Cerebrovascular contributions to aging and Alzheimer's disease in Down syndrome. Biochim Biophys Acta. 2016 May;1862(5):909-14. doi: 10.1016/j.bbadis.2015.11.007. Epub 2015 Nov 26.
PubMed 26593849Sobey CG, Judkins CP, Sundararajan V, Phan TG, Drummond GR, Srikanth VK. Risk of Major Cardiovascular Events in People with Down Syndrome. PLoS One. 2015 Sep 30;10(9):e0137093. doi: 10.1371/journal.pone.0137093. eCollection 2015.
PubMed 26421620Yla-Herttuala S, Luoma J, Nikkari T, Kivimaki T. Down's syndrome and atherosclerosis. Atherosclerosis. 1989 Apr;76(2-3):269-72. doi: 10.1016/0021-9150(89)90110-x.
PubMed 2525042Brattstrom L, Englund E, Brun A. Does Down syndrome support homocysteine theory of arteriosclerosis? Lancet. 1987 Feb 14;1(8529):391-2. doi: 10.1016/s0140-6736(87)91772-7. No abstract available.
PubMed 2880201Murdoch JC, Rodger JC, Rao SS, Fletcher CD, Dunnigan MG. Down's syndrome: an atheroma-free model? Br Med J. 1977 Jul 23;2(6081):226-8. doi: 10.1136/bmj.2.6081.226.
PubMed 141966Alexander M, Petri H, Ding Y, Wandel C, Khwaja O, Foskett N. Morbidity and medication in a large population of individuals with Down syndrome compared to the general population. Dev Med Child Neurol. 2016 Mar;58(3):246-54. doi: 10.1111/dmcn.12868. Epub 2015 Aug 18.
PubMed 26282180Expert Panel on Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents; National Heart, Lung, and Blood Institute. Expert panel on integrated guidelines for cardiovascular health and risk reduction in children and adolescents: summary report. Pediatrics. 2011 Dec;128 Suppl 5(Suppl 5):S213-56. doi: 10.1542/peds.2009-2107C. Epub 2011 Nov 14. No abstract available.
PubMed 22084329Vis JC, Winter MM, Weijerman ME, et al. Down syndrome Congenital heart defects in Down syndrome Prevalence of congenital heart defects. 2019;53(5):1-22
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Health and Risk Factors in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT04735874
- Acronym / sponsor ID
- 00127761
- Conditions
- Down Syndrome, Cardiovascular Risk Factor, Atherosclerosis
- Keywords
- Down Syndrome, Cardiovascular Risk Factor, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, The Hospital for Sick Children
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 3 Feb 2021 (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.
This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with Down Syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children ages 10.0 to 18.0 | – | Other: Evaluate vascular disease risk factors in children with Down Syndrome, Other: Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All children with DS (10.0-18.0 years of age) will be eligible, including those with translocations and mosaicism
Key inclusion criteria (3 listed)
- All children with Down Syndrome (10.0-18.0 years of age)
- Children with translocations and mosaicism
- Children with and without CHD
Key exclusion criteria (3 listed)
- Patients with a history of hypoplastic arch, coarctation or catheter or surgical based aorta interventions
- Patients who are currently treated or have been treated with chemotherapy for cancer or a myeloproliferative disorder within 1 year of the study
- Participants whose parent/legally authorized representative (LAR) perceives the child is not able to cooperate with vascular imaging studies
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 |
|---|---|---|
| Evaluate vascular disease risk factors in children with Down SyndromeWe will determine CV disease risk profiles in children with DS at our centers. We will compare these data to published national norms of children without DS. Risk factor data will include: anthropometric measures; blood pressure; history of congenital heart disease and associated surgery, sleep apnea, hypothyroidism, and cancer; fasting blood draw [lipid panel with subfractions (NMR), insulin, glucose, and CRP]. | Other | Children ages 10.0 to 18.0 |
| Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down SyndromeWe will perform PWV, CIMT, and CD studies in children with DS and compare these data to available data in children without DS. We will also perform multivariable analysis of the influence of combinations of CV disease risk factors on markers of early atherosclerosis in children with DS. Hypothesis: CV disease risk factors will correlate with markers of early atherosclerosis in children with DS but the associations between risk factors and markers of early atherosclerosis will differ between children with DS vs. the general population of children. | Other | Children ages 10.0 to 18.0 |
Primary outcome
The difference in mean pulse wave velocity between children with Down syndrome and published national data in children without Down syndrome at one time point.
Time frame: One day patient visit
Pulse wave velocity (PWV) is a non-invasive imaging measure of arterial stiffness. Pulse wave velocity measures vascular stiffness by evaluating the time for a pressure wave to travel through the aorta. The velocity is determined by the elasticity and geometry of the vessel. PWV will be measured using a SphygmoCor device. With the participant in the supine position and ECG leads attached, the maximal pulsation of the right carotid and right femoral artery will be marked and measured from the suprasternal notch using a tape measure (carotid) and caliper (femoral). A tonometer will record the carotid and femoral impulses. The device calculates PWV as the difference in the carotid-to-distal path length divided by the difference in R-wave-to-waveform times (∆distance/∆time, m/sec). Measurements will be in triplicate and averaged. PWV can be completed in ~30 mins.
7 secondary outcomes
The difference in mean carotid intimal medial thickness between children with Down syndrome and published national data in children without Down syndrome measured at 1 time point.
Time frame: One day patient visit
Correlation of body mass index (BMI) anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Time frame: One day patient visit
Correlation of waist circumference anthropometric cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Time frame: One day patient visit
Correlation of serologic cardiovascular risk factors include fasting lipid panel on PWV and CIMT in children with Down syndrome.
Time frame: One day patient visit
Correlation of serologic cardiovascular risk factors include lipoprotein on PWV and CIMT in children with Down syndrome.
Time frame: One day patient visit
Correlation of serologic cardiovascular risk factors include insulin resistance on PWV and CIMT in children with Down syndrome.
Time frame: One day patient visit
Correlation of clinical cardiovascular risk factors on PWV and CIMT in children with Down syndrome.
Time frame: One day patient visit
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 14 Aug 2023.
- Background: PubMed 22285192Ware AL, Miller DV, Porter CB, Edwards WD. Characterization of atrial morphology and sinus node morphology in heterotaxy syndrome: an autopsy-based study of 41 cases (1950-2008). Cardiovasc Pathol. 2012 Sep-Oct;21(5):421-7. doi: 10.1016/j.carpath.2011.12.007. Epub 2012 Jan 28.
- Background: PubMed 27479044Ware AL, Miller DV, Erickson LK, Menon SC. Marfan syndrome associated aortic disease in neonates and children: a clinical-morphologic review. Cardiovasc Pathol. 2016 Sep-Oct;25(5):418-22. doi: 10.1016/j.carpath.2016.06.002. Epub 2016 Jun 16.
- Background: PubMed 26520246Ware AL, Malmberg E, Delgado JC, Hammond ME, Miller DV, Stehlik J, Kfoury A, Revelo MP, Eckhauser A, Everitt MD. The use of circulating donor specific antibody to predict biopsy diagnosis of antibody-mediated rejection and to provide prognostic value after heart transplantation in children. J Heart Lung Transplant. 2016 Feb;35(2):179-85. doi: 10.1016/j.healun.2015.10.006. Epub 2015 Oct 8.
- Background: PubMed 25064162Ware AL, Tani LY, Weng HY, Wilkes J, Menon SC. Resource utilization and outcomes of infective endocarditis in children. J Pediatr. 2014 Oct;165(4):807-12.e1. doi: 10.1016/j.jpeds.2014.06.026. Epub 2014 Jul 23.
- Background: PubMed 29058030Ware AL, Young PC, Weng C, Presson AP, Minich LL, Menon SC. Prevalence of Coronary Artery Disease Risk Factors and Metabolic Syndrome in Children with Heart Disease. Pediatr Cardiol. 2018 Feb;39(2):261-267. doi: 10.1007/s00246-017-1750-2. Epub 2017 Oct 23.
- Background: PubMed 12431254Glasson EJ, Sullivan SG, Hussain R, Petterson BA, Montgomery PD, Bittles AH. The changing survival profile of people with Down's syndrome: implications for genetic counselling. Clin Genet. 2002 Nov;62(5):390-3. doi: 10.1034/j.1399-0004.2002.620506.x.
- Background: PubMed 29195510Head E, Phelan MJ, Doran E, Kim RC, Poon WW, Schmitt FA, Lott IT. Cerebrovascular pathology in Down syndrome and Alzheimer disease. Acta Neuropathol Commun. 2017 Dec 1;5(1):93. doi: 10.1186/s40478-017-0499-4.
- Background: PubMed 26593849Wilcock DM, Schmitt FA, Head E. Cerebrovascular contributions to aging and Alzheimer's disease in Down syndrome. Biochim Biophys Acta. 2016 May;1862(5):909-14. doi: 10.1016/j.bbadis.2015.11.007. Epub 2015 Nov 26.
- Background: PubMed 26421620Sobey CG, Judkins CP, Sundararajan V, Phan TG, Drummond GR, Srikanth VK. Risk of Major Cardiovascular Events in People with Down Syndrome. PLoS One. 2015 Sep 30;10(9):e0137093. doi: 10.1371/journal.pone.0137093. eCollection 2015.
- Background: PubMed 2525042Yla-Herttuala S, Luoma J, Nikkari T, Kivimaki T. Down's syndrome and atherosclerosis. Atherosclerosis. 1989 Apr;76(2-3):269-72. doi: 10.1016/0021-9150(89)90110-x.
- Background: PubMed 2880201Brattstrom L, Englund E, Brun A. Does Down syndrome support homocysteine theory of arteriosclerosis? Lancet. 1987 Feb 14;1(8529):391-2. doi: 10.1016/s0140-6736(87)91772-7. No abstract available.
- Background: PubMed 141966Murdoch JC, Rodger JC, Rao SS, Fletcher CD, Dunnigan MG. Down's syndrome: an atheroma-free model? Br Med J. 1977 Jul 23;2(6081):226-8. doi: 10.1136/bmj.2.6081.226.
- Data and Statistics on Down Syndrome - Accessed April 13, 2019Link provided by the sponsor.
- R Core Team (2018). R: A language and environment for statistical computing. R Foundation for Statistical Computing. Published 2018.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Down Syndrome
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.
Adam L Ware, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Cardiovascular Risk Factor, run by University of Utah at 1 site in United States.
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 3 inclusion and 3 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
The difference in mean pulse wave velocity between children with Down syndrome and published national data in children without Down syndrome at one time point. (time frame: One day patient visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735874, which also lists 61 linked publications.
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 14 Aug 2023.