ObesityNCT06661434
Prevalence of Obesity Among Adult Patients With Congenital Heart Disease: a Population-based Study
An observational study of Obesity and Congenital Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The study was conductede to examined the prevalence of obesity in a large Danish ACHD cohort, stratified according to age, sex and disease severities. To do so, ACHD patients were matched by age and sex with controls from the contemporary Copenhagen General Population Study Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obesity, Congenital Heart Disease
- How many people
- 7,157 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 30 May 2024
- 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 18 to 100 years
- All sexes
- Adult, Older adult
Study population: The ACHD population in east Denmark
Who may be able to join
- Congenital heart disease
- BMI within the last five years
Who cannot join
- Without BMI or not congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
The study was conductede to examined the prevalence of obesity in a large Danish ACHD cohort, stratified according to age, sex and disease severities. To do so, ACHD patients were matched by age and sex with controls from the contemporary Copenhagen General Population Study
- Conditions
- Obesity, Congenital Heart Disease
- Keywords
- obesity, adult congenital heart disease
- Medical subject headings
- Obesity, Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body mass index
Measured: Within the last five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start1 Sep 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Retrospective
- Enrolment
- 7,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annette Schophuus Jensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661434
- Sponsor's protocol ID
- R-21066074
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obesity Among Adult Patients With Congenital Heart Disease: a Population-based Study
- ClinicalTrials.gov ID
- NCT06661434
- Acronym / sponsor ID
- R-21066074
- Conditions
- Obesity, Congenital Heart Disease
- Keywords
- obesity, adult congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,157 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 28 Oct 2024 (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 study was conductede to examined the prevalence of obesity in a large Danish ACHD cohort, stratified according to age, sex and disease severities. To do so, ACHD patients were matched by age and sex with controls from the contemporary Copenhagen General Population Study
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The ACHD population in east Denmark
Key inclusion criteria (2 listed)
- Congenital heart disease
- BMI within the last five years
Key exclusion criteria (1 listed)
- Without BMI or not congenital heart disease
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
BMI
Time frame: Within the last five years
Body mass index
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 28 Oct 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity and Congenital Heart Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 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 28 Oct 2024. 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 Denmark. 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?
BMI (time frame: Within the last five years). 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 28 Oct 2024.