Young AdultCLARITYNCT05683093
Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood
An observational study of Young Adult and Hypertension in Pregnancy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
The purpose of this study is to understand more about why young people who were born to a hypertensive pregnancy may have increased risk of high blood pressure and are often at increased risk of heart and blood vessel disease later in life. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Young Adult, Hypertension in Pregnancy, Hypertension
- What is being tested?
- History of being born to hypertensive or normal pregnancy
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2022to 31 Jan 2027
- 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 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Of the 200 young adults followed up from the ALSPAC study, 100 will have been born to a hypertensive pregnancy and 100 following an uncomplicated pregnancy. At time of follow-up, they will be 30 to 40 years of age. At the 25-year follow-up in Bristol, there were 610 individuals born to hypertensive pregnancies.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged 30 to 40 years at time of enrolment
- Participant previously took part in the ALSPAC study
- Able (in the investigator's opinion) and willing to comply with all study requirements
- Adequate understanding of verbal and written English
Who cannot join
- Pregnant or lactating when they are due to attend for study visit 1
- Less than six months postpartum
- Planning to donate blood within two weeks prior to study visit 1
- Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study
- Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status
- For exclusion of MRI component only:
- Unsuitable for MRI based on participant screening; the participant may still be included in other parts of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, Oxfordshire, OX3 9DU
Katie Suriano, 01865 226845, clarity@cardiov.ox.ac.uk
About this study
Official title: Cardiovascular Longitudinal the Avon Longitudinal Study of Parents and Children (ALSPAC) Research Investigations Following Hypertensive Pregnancy in Young Adulthood
The purpose of this study is to understand more about why young people who were born to a hypertensive pregnancy may have increased risk of high blood pressure and are often at increased risk of heart and blood vessel disease later in life.
Read the detailed description
Women who develop blood pressure problems during pregnancy are more likely to have high blood pressure (hypertension) in later life as well as heart attacks or strokes. The children born to the pregnancy also tend to have higher blood pressure and are often at increased risk of heart and blood vessel disease later in life. Previous work has shown that children born to pregnancies where the mother has high blood pressure have changes in their blood vessels, heart and brain that can be measured long before they develop high blood pressure or other clinical symptoms. By understanding the pattern of changes cross multiple parts of the body, over a lifetime, the investigators can identify how advanced the underlying disease is for an individual and how their disease is likely to develop over the next few years.
The aim of this study is to understand the heart and blood vessel changes of people born to a hypertensive pregnancy once they are in their 20s and 30s. The investigators then hope to use this information to develop new ways to prevent early onset heart and blood vessel disease in these people.
- Conditions
- Young Adult, Hypertension in Pregnancy, Hypertension, Cardiovascular Diseases, Cerebrovascular Diseases, Vascular Diseases
- Being tested
- History of being born to hypertensive or normal pregnancy
- Keywords
- Young Adult, Birth History, Hypertension in Pregnancy, Cardiovascular Risk, Exercise Capacity
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension, Cardiovascular Diseases, Cerebrovascular Disorders, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
History of being born to hypertensive or normal pregnancyOther
CLARITY is an observational study whereby participants will attend one 4-hr visit the Division of Cardiovascular Medicine, University of Oxford at the John Radcliffe Hospital in Oxford, with the option to split the study visit over two days for convenience.
Participants will be invited by the ALSPAC study team to attend a study visit in Oxford where the investigators will use MRI and other imaging modalities to study the brain, heart, liver, kidneys, and vasculature using standardised protocols. A dataset including information from previous follow-up of these cohorts and the detailed pregnancy data available within ALSPAC will be generated by the study team in Bristol and integrated with available data from the Oxford cohorts.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac right ventricular mass
Magnetic resonance imaging (MRI) assessment of cardiac right ventricular mass indexed to body surface area (in g and g/m^2)
Measured: 30-40 years of old
Secondary outcomes (58)
Cardiac left ventricular mass
MRI assessment of cardiac left ventricular mass indexed to body surface area (in g and g/m^2)
Measured: 30-40 years of old
Cardiac right ventricular end-diastolic volume
MRI assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2)
Measured: 30-40 years of old
Cardiac right ventricular stroke volume
MRI assessment of cardiac right ventricular stroke volume indexed to body surface area (in ml and ml/m^2)
Measured: 30-40 years of old
Cardiac left ventricular end-diastolic volume
MRI assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2)
Measured: 30-40 years of old
Cardiac left ventricular stroke volume
MRI assessment of cardiac left ventricular stroke volume indexed to body surface area (in ml and ml/m^2)
Measured: 30-40 years of old
Cardiac right ventricular systolic function
Echocardiography and MRI assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (in cm) and right ventricular ejection fraction measured by cardiac MRI (in %)
Measured: 30-40 years of old
Cardiac left ventricular systolic function
Echocardiography and MRI assessment of left ventricular systolic function: left ventricular ejection fraction (in %)
Measured: 30-40 years of old
Cardiac right ventricular diastolic function
Echocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)
Measured: 30-40 years of old
Cardiac left ventricular diastolic function
Echocardiography assessment of left ventricular (LV) diastolic function: LV Doppler early/late diastolic mitral inflow velocity ratio (E/A) and LV early Doppler inflow velocity/peak early diastolic tissue velocity ratio (E/e')
Measured: 30-40 years of old
Morphology of the right ventricles
MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis
Measured: 30-40 years of old
Morphology of the left ventricles
MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis
Measured: 30-40 years of old
Aortic compliance
Aortic distensibility by MRI (in 10^-3 mmHg^-1) and aortic/central blood pressure by cuff measurement (in mmHg)
Measured: 30-40 years of old
Intra-hepatic lipid content, steatohepatitis and hepatic fibrosis
MRI assessment of the liver to quantify proton density fat fraction (in %) and fibro-inflammatory status from iron-corrected T1 (cT1 in ms)
Measured: 30-40 years of old
Renal function
MRI assessment of fibro-inflammatory status from T1 (in ms) and surrogate measure of blood perfusion from T2* (in ms) and volumes (in ml and ml/m^2)
Measured: 30-40 years of old
Oxygen uptake across sub-maximal and peak exercise
Cardiopulmonary exercise test to measure oxygen uptake (VO2 in ml/kg/min)
Measured: 30-40 years of old
Carbon dioxide exchange kinetics across sub-maximal and peak exercise
Cardiopulmonary exercise test to measure respiratory exchange ratio (RER calculated as carbon dioxide production divided by oxygen consumption)
Measured: 30-40 years of old
Retinal arteriolar structure
Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging
Measured: 30-40 years of old
Retinal venular structure
Central retinal venular equivalent (CRVE in μm) measured using retinal imaging
Measured: 30-40 years of old
Retinal arteriolar-to-venular diameter ratio (AVR)
The ratio of average retinal arteriolar diameter (CRAE in μm) and average retinal venous diameter (CRVE in μm) measured using retinal imaging
Measured: 30-40 years of old
Ear microvascular structure
Superior crus of anti-helix earlobe vascular caliber (in μm) measured using ear vascular imaging
Measured: 30-40 years of old
Lung function
The forced expiratory volume in one second (FEV1 in L), forced vital capacity (FVC in L), and the ratio of FEV1 to FVC (FEV1/FVC) measured using spirometry
Measured: 30-40 years of old
Objective measure of physical activity
The amount of moderate to vigorous physical activity (in h/week) and vigorous physical activity (in h/week) measured using wrist worn accelerometer
Measured: 30-40 years of old
Total white matter volume
Total white matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI
Measured: 30-40 years of old
Total grey matter volume
Total grey matter volumes (in mm3) assessed on T1-weighted sequence of brain MRI
Measured: 30-40 years of old
Subcortical brain volume of thalamus
Subcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI
Measured: 30-40 years of old
Subcortical brain volume of hippocampus
Subcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI
Measured: 30-40 years of old
White matter hyperintensities volume
Total volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI
Measured: 30-40 years of old
White matter hyperintensities count
The number of white matter hyperintensities on T2-weighted sequence of brain MRI
Measured: 30-40 years of old
Cerebral vessel lumen diameter
Cerebral vessel lumen diameter (in μm) assessed on the time-of-flight sequence of brain MRI
Measured: 30-40 years of old
Cerebral vessel density
Cerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI
Measured: 30-40 years of old
Cerebral vessel tortuosity
The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI
Measured: 30-40 years of old
Whole brain grey matter perfusion or cerebral blood flow (CBF)
Whole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain MRI
Measured: 30-40 years of old
Arterial cerebral blood volume fraction
Arterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI
Measured: 30-40 years of old
Circulating vascular endothelial growth factor A (VEGF-A) as an angiogenic marker
The level of VEGF-A (in pg/mL) measured from plasma blood samples
Measured: 30-40 years of old
Circulating soluble endoglin (sENG) as an angiogenic marker
The level of sENG (in ng/mL) measured from plasma blood samples
Measured: 30-40 years of old
Circulating soluble fms-like tyrosine kinase-1 (sFlt-1) as an antiangiogenic marker
The level of sFlt-1 (in pg/mL) measured from plasma blood samples
Measured: 30-40 years of old
Circulating total cholesterol as a metabolic marker
The level of total cholesterol (in mmol/L) measured from serum blood samples
Measured: 30-40 years of old
Circulating high-density lipoprotein as a metabolic marker
The level of HDL (in mmol/L) measured from serum blood samples
Measured: 30-40 years of old
Circulating low-density lipoprotein as a metabolic marker
The level of LDL (in mmol/L) measured from serum blood samples
Measured: 30-40 years of old
Circulating triglycerides as a metabolic marker
The level of triglycerides (in mmol/L) measured from serum blood samples
Measured: 30-40 years of old
Circulating fasting glucose concentration as a metabolic marker
The level of fasting glucose (in mmol/L) measured from whole blood samples
Measured: 30-40 years of old
Circulating fasting insulin concentration as a metabolic marker
The level of fasting insulin (in pmol/L) measured from serum blood samples
Measured: 30-40 years of old
Insulin resistance index (HOMA-IR) as a metabolic marker
The index calculated as fasting glucose (in mmol/L) x fasting insulin (in μIU/mL) ÷ 22.5
Measured: 30-40 years of old
Circulating C-reactive protein (CRP) as an inflammatory marker
The level of CRP (in mmol/L) measured from serum blood samples
Measured: 30-40 years of old
Circulating soluble intercellular adhesion molecule-1 (sICAM-1) as an inflammatory marker
The level of sICAM-1 (in ng/mL) measured from serum blood samples
Measured: 30-40 years of old
Circulating soluble vascular cell adhesion molecule-1 (sVCAM-1) as an inflammatory marker
The level of sVCAM-1 (in ng/mL) measured from serum blood samples
Measured: 30-40 years of old
Body weight
Body weight measured in kg
Measured: 30-40 years of old
Body height
Body height measured in m
Measured: 30-40 years of old
Body mass index
Body weight divided by the square of height (in kg/m2)
Measured: 30-40 years of old
Mid-arm circumference
Mid-arm circumference measured in cm
Measured: 30-40 years of old
Waist-to-hip ratio
The ratio of waist circumference (in cm) to hip circumference (in cm)
Measured: 30-40 years of old
Systolic blood pressure
Resting brachial blood pressure measurement (in mmHg)
Measured: 30-40 years of old
Diastolic blood pressure
Resting brachial blood pressure measurement (in mmHg)
Measured: 30-40 years of old
Mean arterial pressure
The average arterial pressure from resting brachial blood pressure measurement (in mmHg)
Measured: 30-40 years of old
Pulse pressure
The difference between systolic and diastolic blood pressure (in mmHg)
Measured: 30-40 years of old
Heart rate
The frequency of the heart contractions per minute (in beats per minute or bpm)
Measured: 30-40 years of old
Smoking status
The number and percentage of current smokers
Measured: 30-40 years of old
Alcohol consumption
Weekly alcoholic unit intake (in units per week)
Measured: 30-40 years of old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start17 Nov 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young AdultStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bristol
- Responsible party
- Sponsor
- Investigators
- Adam J Lewandowski, Principal investigator, Cardiovascular Clinical Research Facility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683093
- Sponsor's protocol ID
- 22/WA/0227
- Acronym
- CLARITY
- Status last verified
- Jan 2023
- First submitted
- 7 Nov 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Longitudinal the Avon Longitudinal Study of Parents and Children (ALSPAC) Research Investigations Following Hypertensive Pregnancy in Young Adulthood
- ClinicalTrials.gov ID
- NCT05683093
- Acronym / sponsor ID
- CLARITY / 22/WA/0227
- Conditions
- Young Adult, Hypertension in Pregnancy, Hypertension, Cardiovascular Diseases, Cerebrovascular Diseases, Vascular Diseases
- Keywords
- Young Adult, Birth History, Hypertension in Pregnancy, Cardiovascular Risk, Exercise Capacity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- University of Bristol
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 12 Jan 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 purpose of this study is to understand more about why young people who were born to a hypertensive pregnancy may have increased risk of high blood pressure and are often at increased risk of heart and blood vessel disease later in life.
Detailed description
Women who develop blood pressure problems during pregnancy are more likely to have high blood pressure (hypertension) in later life as well as heart attacks or strokes. The children born to the pregnancy also tend to have higher blood pressure and are often at increased risk of heart and blood vessel disease later in life. Previous work has shown that children born to pregnancies where the mother has high blood pressure have changes in their blood vessels, heart and brain that can be measured long before they develop high blood pressure or other clinical symptoms. By understanding the pattern of changes cross multiple parts of the body, over a lifetime, the investigators can identify how advanced the underlying disease is for an individual and how their disease is likely to develop over the next few years.
The aim of this study is to understand the heart and blood vessel changes of people born to a hypertensive pregnancy once they are in their 20s and 30s. The investigators then hope to use this information to develop new ways to prevent early onset heart and blood vessel disease in these people.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Of the 200 young adults followed up from the ALSPAC study, 100 will have been born to a hypertensive pregnancy and 100 following an uncomplicated pregnancy. At time of follow-up, they will be 30 to 40 years of age. At the 25-year follow-up in Bristol, there were 610 individuals born to hypertensive pregnancies.
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the study
- Male or female, aged 30 to 40 years at time of enrolment
- Participant previously took part in the ALSPAC study
- Able (in the investigator's opinion) and willing to comply with all study requirements
- Adequate understanding of verbal and written English
Key exclusion criteria (7 listed)
- Pregnant or lactating when they are due to attend for study visit 1
- Less than six months postpartum
- Planning to donate blood within two weeks prior to study visit 1
- Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study
- Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status
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 |
|---|---|---|
| History of being born to hypertensive or normal pregnancyCLARITY is an observational study whereby participants will attend one 4-hr visit the Division of Cardiovascular Medicine, University of Oxford at the John Radcliffe Hospital in Oxford, with the option to split the study visit over two days for convenience. Participants will be invited by the ALSPAC study team to attend a study visit in Oxford where the investigators will use MRI and other imaging modalities to study the brain, heart, liver, kidneys, and vasculature using standardised protocols. A dataset including information from previous follow-up of these cohorts and the detailed pregnancy data available within ALSPAC will be generated by the study team in Bristol and integrated with available data from the Oxford cohorts. | Other | – |
Primary outcome
Cardiac right ventricular mass
Time frame: 30-40 years of old
Magnetic resonance imaging (MRI) assessment of cardiac right ventricular mass indexed to body surface area (in g and g/m^2)
58 secondary outcomes
Cardiac left ventricular mass
Time frame: 30-40 years of old
Cardiac right ventricular end-diastolic volume
Time frame: 30-40 years of old
Cardiac right ventricular stroke volume
Time frame: 30-40 years of old
Cardiac left ventricular end-diastolic volume
Time frame: 30-40 years of old
Cardiac left ventricular stroke volume
Time frame: 30-40 years of old
Cardiac right ventricular systolic function
Time frame: 30-40 years of old
Cardiac left ventricular systolic function
Time frame: 30-40 years of old
Cardiac right ventricular diastolic function
Time frame: 30-40 years of old
Cardiac left ventricular diastolic function
Time frame: 30-40 years of old
Morphology of the right ventricles
Time frame: 30-40 years of old
Morphology of the left ventricles
Time frame: 30-40 years of old
Aortic compliance
Time frame: 30-40 years of old
Intra-hepatic lipid content, steatohepatitis and hepatic fibrosis
Time frame: 30-40 years of old
Renal function
Time frame: 30-40 years of old
Oxygen uptake across sub-maximal and peak exercise
Time frame: 30-40 years of old
Carbon dioxide exchange kinetics across sub-maximal and peak exercise
Time frame: 30-40 years of old
Retinal arteriolar structure
Time frame: 30-40 years of old
Retinal venular structure
Time frame: 30-40 years of old
Retinal arteriolar-to-venular diameter ratio (AVR)
Time frame: 30-40 years of old
Ear microvascular structure
Time frame: 30-40 years of old
Lung function
Time frame: 30-40 years of old
Objective measure of physical activity
Time frame: 30-40 years of old
Total white matter volume
Time frame: 30-40 years of old
Total grey matter volume
Time frame: 30-40 years of old
Subcortical brain volume of thalamus
Time frame: 30-40 years of old
Subcortical brain volume of hippocampus
Time frame: 30-40 years of old
White matter hyperintensities volume
Time frame: 30-40 years of old
White matter hyperintensities count
Time frame: 30-40 years of old
Cerebral vessel lumen diameter
Time frame: 30-40 years of old
Cerebral vessel density
Time frame: 30-40 years of old
Cerebral vessel tortuosity
Time frame: 30-40 years of old
Whole brain grey matter perfusion or cerebral blood flow (CBF)
Time frame: 30-40 years of old
Arterial cerebral blood volume fraction
Time frame: 30-40 years of old
Circulating vascular endothelial growth factor A (VEGF-A) as an angiogenic marker
Time frame: 30-40 years of old
Circulating soluble endoglin (sENG) as an angiogenic marker
Time frame: 30-40 years of old
Circulating soluble fms-like tyrosine kinase-1 (sFlt-1) as an antiangiogenic marker
Time frame: 30-40 years of old
Circulating total cholesterol as a metabolic marker
Time frame: 30-40 years of old
Circulating high-density lipoprotein as a metabolic marker
Time frame: 30-40 years of old
Circulating low-density lipoprotein as a metabolic marker
Time frame: 30-40 years of old
Circulating triglycerides as a metabolic marker
Time frame: 30-40 years of old
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 12 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Adam J Lewandowski principal investigator
Cardiovascular Clinical Research Facility
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 Young Adult and Hypertension in Pregnancy, run by University of Oxford at 1 site in United Kingdom.
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 5 inclusion and 7 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 12 Jan 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 Kingdom. 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 Katie Suriano (01865 226845, clarity@cardiov.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac right ventricular mass (time frame: 30-40 years of old). 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 12 Jan 2023.