Coarctation of the AortaNCT07134621
Target Organ Damage in Patients With Repaired Coarctation of Aorta and Exercise Induced Hypertension
An observational study of Coarctation of the Aorta, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The goal of this observational study is to obtain data on the effect of exercise induced hypertension on target organs in adult patients with repaired coarctation of the aorta. The main questions it aims to answer are: patients with exercise induced hypertension have signs of hypertensive heart disease? patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coarctation of the Aorta
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 16 Jul 2025to Aug 2026
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years and older with repaired coarctation of aorta.
Who may be able to join
- adult patients aged 18 years and older
- history of coarctation of aorta repair
Who cannot join
- haemodynamically significant recoarctation
- arterial hypertension at rest
- antihypertensive therapy
- associated haemodynamically significant valvular heart disease
- associated complex congenital heart disease
- advanced heart failure
- symptomatic arrhythmias
- cognitive or physical limitations to perform exercise stress testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to obtain data on the effect of exercise induced hypertension on target organs in adult patients with repaired coarctation of the aorta. The main questions it aims to answer are:
- patients with exercise induced hypertension have signs of hypertensive heart disease?
- patients with exercise induced hypertension have increased arterial stiffness?
- patients with exercise induced hypertension have signs of hypertensive renal damage? Participants will be invited for an outpatient appointment during which medical history and physical investigation will be performed. They will undergo cardiopulmonary exercise testing during which blood pressure will be measured regularly. Transthoracic echocardiography will also be performed as well as assessment of arterial stiffness by measuring pulse wave velocity. Renal function will be assessed by blood and urine analysis.
- Conditions
- Coarctation of the Aorta
- Medical subject headings
- Aortic Coarctation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with EIH who also have signs of hypertensive heart disease.
Measured: At enrolment.
Number of patients with EIH and increased arterial stiffness.
Measured: At enrolment.
Number of patients with EIH and signs of hypertensive renal damage.
Measured: At enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start16 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coarctation of the AortaStudies 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
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134621
- Sponsor's protocol ID
- 0120-135/2023/6
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Organ Damage in Patients With Repaired Coarctation of Aorta and Exercise Induced Hypertension
- ClinicalTrials.gov ID
- NCT07134621
- Acronym / sponsor ID
- 0120-135/2023/6
- Conditions
- Coarctation of the Aorta
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 21 Aug 2025 (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 goal of this observational study is to obtain data on the effect of exercise induced hypertension on target organs in adult patients with repaired coarctation of the aorta. The main questions it aims to answer are:
- patients with exercise induced hypertension have signs of hypertensive heart disease?
- patients with exercise induced hypertension have increased arterial stiffness?
- patients with exercise induced hypertension have signs of hypertensive renal damage? Participants will be invited for an outpatient appointment during which medical history and physical investigation will be performed. They will undergo cardiopulmonary exercise testing during which blood pressure will be measured regularly. Transthoracic echocardiography will also be performed as well as assessment of arterial stiffness by measuring pulse wave velocity. Renal function will be assessed by blood and urine analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years and older with repaired coarctation of aorta.
Key inclusion criteria (2 listed)
- adult patients aged 18 years and older
- history of coarctation of aorta repair
Key exclusion criteria (8 listed)
- haemodynamically significant recoarctation
- arterial hypertension at rest
- antihypertensive therapy
- associated haemodynamically significant valvular heart disease
- associated complex 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
Number of patients with EIH who also have signs of hypertensive heart disease.
Time frame: At enrolment.
Number of patients with EIH and increased arterial stiffness.
Time frame: At enrolment.
Number of patients with EIH and signs of hypertensive renal damage.
Time frame: At enrolment.
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 30 Apr 2026.
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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.
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 Coarctation of the Aorta, 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 2 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 2026. 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?
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?
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?
Number of patients with EIH who also have signs of hypertensive heart disease. (time frame: At enrolment.). 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 30 Apr 2026.