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NCT Number: NCT07771023

Effects of Exercise 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.

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Key information

Conditions

Coarctation of the Aorta Aortic Coarctation Behavior Cardiovascular Abnormalities Cardiovascular Diseases Coarctation of Aorta Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana, Ljubljana, Slovenia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • surgically repaired coarctation of the aorta,
  • age at least 18 years, and
  • signed informed consent form.

Exclusion criteria

  • 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.

Treatment and study plan

Outpatient high-intensity interval training (HIIT)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

    Assessment of average systolic pressure during sleep and wakefulness, measured using 24-hour ambulatory blood pressure monitoring.

  2. Echocardiographic parameters

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Assessment of standard echocardiographic measures of cardiac structure and function, including left ventricular global longitudinal strain (GLS).

  3. 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.

    Ultrasound assessment of endothelial function of the right radial artery, measured by flow-mediated dilation (FMD).

  4. Heart rate variability

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Assessment of heart rate variability using high-resolution electrocardiography.

  5. 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.

    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).

  6. Self-reported physical activity

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Self-reported physical activity level, assessed using the standardised International Physical Activity Questionnaire (IPAQ).

Other outcomes

  1. Body composition

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Assessment of body composition using bioelectrical impedance analysis.

  2. Standard laboratory panel

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Assessment of standard laboratory parameters: electrolytes, renal function markers, liver function tests.

  3. NT-proBNP

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Assessment of NT-proBNP

  4. Extended lipid panel

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Assessment extended lipid panel, including Lp(a).

  5. Thyroid hormone level

    Time frame: At baseline and on follow-up assessment, with follow-up occurring within 3-12 months after baseline.

    Assessment of thyroid hormones.

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Pelicon, MD

CONTACT

[email protected]

+38615228011

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University Medical Centre Maribor

Registry information

Official study title

Effects of Exercise on Select Indicators of Cardiovascular Health in Patients With Repaired Coarctation of the Aorta

Acronym: KOREKT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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