Acyanotic Congenital Heart DiseaseNCT04891081
Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease
An observational study of Acyanotic Congenital Heart Disease and Cyanotic Congenital Heart Disease, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acyanotic Congenital Heart Disease, Cyanotic Congenital Heart Disease, Pheochromocytoma
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Nov 2019to 9 Jun 2021
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with congenital heart disease attending regular follow ups.
Who may be able to join
- patients with congenital heart disease attending regular follow up
Who cannot join
- missing main data in medical documentation
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
Ljubljana, 1000
Mojca Jensterle, MD, PhD, 0o3861 522 50 5, mojca.jensterlesever@kclj.si
About this study
The aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress.
- Conditions
- Acyanotic Congenital Heart Disease, Cyanotic Congenital Heart Disease, Pheochromocytoma, Paraganglioma
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cyanotic Congenital Heart Disease | Not described | |
| Patients with acyanotic Congenital Heart Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma metanephrine level
Level of plasma metanephrine
Measured: baseline, one point of time in a cross-sectional study
Plasma normetanephrine level
Level of plasma normetanephrine
Measured: baseline, one point of time in a cross-sectional study
Secondary outcomes (1)
Hypoxemia
Length of hypoxemia presence in years
Measured: baseline, one point of time in a cross-sectional study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start1 Nov 2019
- Primary completion31 May 2021 (estimated)
- Study completion9 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acyanotic Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- 50 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, University Rehabilitation Institute, Republic of Slovenia
- Responsible party
- Principal investigator, Mojca Jensterle, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891081
- Sponsor's protocol ID
- 0000
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 18 May 2021
- Results posted
- 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 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Metanephrines in Patients With Cyanotic and Acyanotic Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT04891081
- Acronym / sponsor ID
- 0000
- Conditions
- Acyanotic Congenital Heart Disease, Cyanotic Congenital Heart Disease, Pheochromocytoma, Paraganglioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, University Rehabilitation Institute, Republic of Slovenia
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 9 Jun 2021 (estimated)
- First posted
- 18 May 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.
The aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cyanotic Congenital Heart Disease | – | – |
| Patients with acyanotic Congenital Heart Disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with congenital heart disease attending regular follow ups.
Key inclusion criteria (1 listed)
- patients with congenital heart disease attending regular follow up
Key exclusion criteria (1 listed)
- missing main data in medical documentation
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
Plasma metanephrine level
Time frame: baseline, one point of time in a cross-sectional study
Level of plasma metanephrine
Plasma normetanephrine level
Time frame: baseline, one point of time in a cross-sectional study
Level of plasma normetanephrine
1 secondary outcome
Hypoxemia
Time frame: baseline, one point of time in a cross-sectional study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- 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.
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 Acyanotic Congenital Heart Disease and Cyanotic Congenital Heart Disease, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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: status not confirmed, as of the sponsor's last update on 18 May 2021. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mojca Jensterle, MD, PhD (03861 522 35 64, mojca.jensterlesever@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma metanephrine level (time frame: baseline, one point of time in a cross-sectional study). The study lists 2 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 18 May 2021.