Coarctation of the AortaKOREKTNCT07771023
Effects of Exercise in Patients With Repaired Coarctation of the Aorta
A study testing Outpatient high-intensity interval training (HIIT) and Home-based high-intensity interval training (HIIT) in people with Coarctation of the Aorta and Coarctation of Aorta, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
Trial summary
This interventional study will investigate the effects of high-intensity interval training (HIIT) in adults with repaired coarctation of the aorta. Participants will be randomised into three groups: HIIT performed at home, HIIT performed in a supervised outpatient setting, or a control group receiving usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coarctation of the Aorta, Coarctation of Aorta
- What is being tested?
- Outpatient high-intensity interval training (HIIT) and Home-based high-intensity interval training (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSlovenia
- Study dates
- Aug 2026to Oct 2027
- Phase
- Interventional
- 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
Who may be able to join
- surgically repaired coarctation of the aorta,
- age at least 18 years, and
- signed informed consent form.
Who cannot join
- residual aortic stenosis (gradient across the narrowing >20 mmHg),
- presence of ascending aortic aneurysm,
- recent major cardiovascular event or other event requiring hospitalization (event less than 2 months before inclusion),
- unstable rhythm disturbances,
- unstable or low-threshold angina pectoris,
- NYHA class III or IV heart failure, and
- pregnancy.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia2 sites
University Medical Centre Ljubljana
Ljubljana, 1000
University Medical Centre Maribor
Maribor, 2000
About this study
Official title: Effects of Exercise on Select Indicators of Cardiovascular Health in Patients With Repaired Coarctation of the Aorta
This interventional study will investigate the effects of high-intensity interval training (HIIT) in adults with repaired coarctation of the aorta. Participants will be randomised into three groups: HIIT performed at home, HIIT performed in a supervised outpatient setting, or a control group receiving usual care. The two HIIT protocols will be identical in intensity and progression, individually prescribed for each patient.
The study will evaluate the effects of HIIT on exercise capacity, health-related quality of life, blood pressure response to exercise, and other select measures of cardiovascular health, including vascular stiffness and endothelial function. In addition, the study will examine the acute effects of a single exercise session on arterial stiffness.
- Conditions
- Coarctation of the Aorta, Coarctation of Aorta
- Being tested
- Outpatient high-intensity interval training (HIIT), Home-based high-intensity interval training (HIIT)
- Keywords
- exercise, HIIT, home-based exercise, exercise training, cardiopulmonary exercise testing, arterial stiffness, hypertensive reaction, congenital heart disease
- Medical subject headings
- Aortic Coarctation, Motor Activity, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient high-intensity interval training (HIIT)Behavioural
A structured exercise programme performed under direct supervision in an outpatient/clinical setting on a stationary bicycle or treadmill, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down.
Interval intensity will be individually determined for each patient.
Home-based high-intensity interval training (HIIT)Behavioural
A structured exercise programme performed independently at home, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down.
Interval intensity will be individually determined for each patient.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient HIIT | Experimental | Anticipated number of patients: 15.
Participants will complete a structured high-intensity interval training (HIIT) programme performed in an outpatient setting. Intensity and progression are identical to the home-based HIIT arm. Receives: Behavioral: Outpatient high-intensity interval training (HIIT) |
| Home-based HIIT | Experimental | Anticipated number of patients: 15.
Participants will complete a structured high-intensity interval training (HIIT) programme performed independently at home. Intensity and progression are identical to the outpatient HIIT arm. Receives: Behavioral: Home-based high-intensity interval training (HIIT) |
| Control (usual care) | No intervention | Anticipated number of patients: 15. Participants will receive usual care, consisting of general counselling on physical activity performed at home, without a structured or supervised exercise training programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak on cardiopulmonary exercise testing (CPET)
Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves aerobic capacity (measured by VO2peak) more than a home-based HIIT program or usual care.
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Health-related quality of life
Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves health-related quality of life, assessed using the standardised SF-36 and EQ-5D questionnaires, more than a home-based HIIT programme or usual care.
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Ratio of peak systolic blood pressure to peak workload (mmHg/W) on CPET
Hypothesis: The outpatient high-intensity interval training (HIIT) programme reduces the ratio between peak systolic blood pressure and peak workload achieved during exercise testing more than a home-based HIIT programme or usual care.
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Secondary outcomes (6)
Mean 24-hour systolic blood pressure
Assessment of average systolic pressure during sleep and wakefulness, measured using 24-hour ambulatory blood pressure monitoring.
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Echocardiographic parameters
Assessment of standard echocardiographic measures of cardiac structure and function, including left ventricular global longitudinal strain (GLS).
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Endothelial function of the right radial artery (flow-mediated dilation, FMD)
Ultrasound assessment of endothelial function of the right radial artery, measured by flow-mediated dilation (FMD).
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Heart rate variability
Assessment of heart rate variability using high-resolution electrocardiography.
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Biomarkers associated with vascular stiffness and atherosclerosis
Assessment of circulating biomarkers associated with vascular stiffness and atherosclerosis, including atrial natriuretic peptide (ANP), growth/differentiation factor 15 (GDF-15), matrix metalloproteinase 1 (MMP-1), interleukin-33 receptor (IL-33/ST2), brain-derived neurotrophic factor (BDNF), galectin-3, myeloperoxidase, and tissue inhibitor of metalloproteinase 1 (TIMP-1).
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Self-reported physical activity
Self-reported physical activity level, assessed using the standardised International Physical Activity Questionnaire (IPAQ).
Measured: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Maribor
- Responsible party
- Principal investigator, Kevin Pelicon, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771023
- Sponsor's protocol ID
- 0120-101/2025-2711-4
- Acronym
- KOREKT
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Select Indicators of Cardiovascular Health in Patients With Repaired Coarctation of the Aorta
- ClinicalTrials.gov ID
- NCT07771023
- Acronym / sponsor ID
- KOREKT / 0120-101/2025-2711-4
- Conditions
- Coarctation of the Aorta, Coarctation of Aorta
- Keywords
- exercise, HIIT, home-based exercise, exercise training, cardiopulmonary exercise testing, arterial stiffness, hypertensive reaction, congenital heart disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University Medical Centre Maribor
- Study start
- Aug 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 18 Aug 2026 (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 interventional study will investigate the effects of high-intensity interval training (HIIT) in adults with repaired coarctation of the aorta. Participants will be randomised into three groups: HIIT performed at home, HIIT performed in a supervised outpatient setting, or a control group receiving usual care. The two HIIT protocols will be identical in intensity and progression, individually prescribed for each patient.
The study will evaluate the effects of HIIT on exercise capacity, health-related quality of life, blood pressure response to exercise, and other select measures of cardiovascular health, including vascular stiffness and endothelial function. In addition, the study will examine the acute effects of a single exercise session on arterial stiffness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Outpatient HIIT | Experimental | Behavioral: Outpatient high-intensity interval training (HIIT)Anticipated number of patients: 15. Participants will complete a structured high-intensity interval training (HIIT) programme performed in an outpatient setting. Intensity and progression are identical to the home-based HIIT arm. |
| Home-based HIIT | Experimental | Behavioral: Home-based high-intensity interval training (HIIT)Anticipated number of patients: 15. Participants will complete a structured high-intensity interval training (HIIT) programme performed independently at home. Intensity and progression are identical to the outpatient HIIT arm. |
| Control (usual care) | No intervention | –Anticipated number of patients: 15. Participants will receive usual care, consisting of general counselling on physical activity performed at home, without a structured or supervised exercise training programme. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- surgically repaired coarctation of the aorta,
- age at least 18 years, and
- signed informed consent form.
Key exclusion criteria (7 listed)
- residual aortic stenosis (gradient across the narrowing >20 mmHg),
- presence of ascending aortic aneurysm,
- recent major cardiovascular event or other event requiring hospitalization (event less than 2 months before inclusion),
- unstable rhythm disturbances,
- unstable or low-threshold angina pectoris,
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 |
|---|---|---|
| Outpatient high-intensity interval training (HIIT)A structured exercise programme performed under direct supervision in an outpatient/clinical setting on a stationary bicycle or treadmill, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down. Interval intensity will be individually determined for each patient. | Behavioural | Outpatient HIIT |
| Home-based high-intensity interval training (HIIT)A structured exercise programme performed independently at home, consisting of 36 one-hour sessions over 2-4 months (approximately 2-3 sessions per week). Each session will comprise 8 five-minute intervals, each consisting of 2 minutes at 85-95% of the heart rate reached at VO2peak, followed by 3 minutes of active recovery. The interval block will be preceded by a 5-minute active warm-up and followed by a 5-minute active cool-down. Interval intensity will be individually determined for each patient. | Behavioural | Home-based HIIT |
Primary outcome
VO2peak on cardiopulmonary exercise testing (CPET)
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves aerobic capacity (measured by VO2peak) more than a home-based HIIT program or usual care.
Health-related quality of life
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Hypothesis: The outpatient high-intensity interval training (HIIT) programme improves health-related quality of life, assessed using the standardised SF-36 and EQ-5D questionnaires, more than a home-based HIIT programme or usual care.
Ratio of peak systolic blood pressure to peak workload (mmHg/W) on CPET
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Hypothesis: The outpatient high-intensity interval training (HIIT) programme reduces the ratio between peak systolic blood pressure and peak workload achieved during exercise testing more than a home-based HIIT programme or usual care.
6 secondary outcomes
Mean 24-hour systolic blood pressure
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Echocardiographic parameters
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Endothelial function of the right radial artery (flow-mediated dilation, FMD)
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Heart rate variability
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Biomarkers associated with vascular stiffness and atherosclerosis
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
Self-reported physical activity
Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared upon reasonable request.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient high-intensity interval training (HIIT) and Home-based high-intensity interval training (HIIT) in people with Coarctation of the Aorta and Coarctation of Aorta, run by University Medical Centre Ljubljana at 2 sites 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 3 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: enrolling by invitation, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
VO2peak on cardiopulmonary exercise testing (CPET) (time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.). 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 25 Aug 2026.