Clinical trial NCT06715137: Microvascular Dysfunction in Adults with Congenital Heart Disease and the Effect of Exercise Training
Official title: Microvascular Dysfunction in Adults with Congenital Heart Disease and the Effect of Exercise Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Defect
Congenital Heart Disease
Microvascular Dysfunction
Exercise Training
Oxidative Stress
Coronary Microvascular Dysfunction
Peripheral Microvascular Dysfunction
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this prospective cohort study is to deepen the understanding of the pathophysiology in adults with congenital heart disease (CHD). Through this research, the investigators aim to identify potential strategies to improve the prevention and treatment of these patients. In this context, the effects of exercise training will also be assessed. The main questions it aims to answer are:

* Is coronary microvascular dysfunction (MVD) present in adults with diverse types of CHD?
* Is peripheral MVD present in adults with diverse types of CHD?
* Are coronary and peripheral MVD correlated in adults with diverse types of CHD?
* Is microvascular function correlated with inflammation and oxidative stress in adults with diverse types of CHD?
* Are inflammation and oxidative stress correlated with ventricular function in adults with diverse types of CHD?
* Are MVD and diminished ventricular function interrelated and associated with reduced exercise capacity in adults with diverse types of CHD?
* Does exercise training in adults with CHD result in improvements in coronary and peripheral microvascular function, inflammation and oxidative stress, biventricular function, muscle strength, exercise capacity and quality of life?

For the last research question, patients were randomized to receive either conventional care or home-based aerobic and strength exercise training.


Eligibility criteria: Inclusion Criteria:

* adults with congenital heart disease: as many different types of CHD as possible were incorporated
* New York Heart Association (NYHA) class I-II
* who visited the out-patient clinic at the Antwerp University Hospital

Exclusion Criteria:

* smoking
* body mass index \>35 kg/m²
* professional endurance athlete
* the presence of macrovascular coronary artery disease
* diabetes mellitus
* a systemic disease (e.g., malignancies, acute and chronic inflammatory diseases in the preceding 3 months)
* a contraindication for adenosine administration.

Primary outcomes:
measure: Coronary microvascular function: coronary flow reserve
timeFrame: on both study visits (at baseline and at 16 weeks)
Secondary outcomes:
measure: Peripheral microvascular function: reactive hyperemia index
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Peripheral microvascular function: Framingham modified reactive hyperemia index
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Carotid arterial wall thickness: carotid intima-media thickness
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Large artery stiffness: pulse wave velocity
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Large artery stiffness: augmentation index
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Inflammation: white blood cell count
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Inflammation: high-sensitivity C-reactive protein
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Oxidative stress: superoxide anion radical
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Left ventricular function: ejection fraction
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Left ventricular function: global longitudinal strain
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Right ventricular function: fractional area change
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Right ventricular function: tricuspid annular plane systolic excursion
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Right ventricular function: tissue Doppler imaging systolic velocity
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Right ventricular function: peak systolic global longitudinal strain
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Quality of life: RAND 36-Item Health Survey 1.0
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Quality of life: EuroQol visual analogue scale
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Exercise capacity: percent-predicted peak oxygen consumption
timeFrame: on both study visits (at baseline and at 16 weeks)
measure: Muscle strength: one-repetition maximum
timeFrame: on both study visits (at baseline and at 16 weeks)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: Vanreusel I, Vermeulen D, Goovaerts I, Stoop T, Ectors B, Cornelis J, Hens W, de Bliek E, Heuten H, Van Craenenbroeck EM, Van Berendoncks A, Segers VFM, Briede JJ. Circulating Reactive Oxygen Species in Adults with Congenital Heart Disease. Antioxidants (Basel). 2022 Nov 30;11(12):2369. doi: 10.3390/antiox11122369.
citation: Vanreusel I, Taeymans J, Van Craenenbroeck E, Segers VFM, Van Berendoncks A, Briedé JJ, et al. Oxidative Stress in Patients with Congenital Heart Disease: A Systematic Review. Advances in Redox Research. 2024:100109
citation: Vanreusel I, Taeymans J, Van Craenenbroeck E, Segers VFM, Van Berendoncks A, Briede JJ, Hens W. Elevated oxidative stress in patients with congenital heart disease and the effect of cyanosis: a meta-analysis. Free Radic Res. 2023 May-Jun;57(6-12):470-486. doi: 10.1080/10715762.2023.2284639. Epub 2023 Dec 26.
citation: Vanreusel I, Hens W, Van Craenenbroeck E, Van Berendoncks A, Segers VFM. Peripheral Microvascular Dysfunction in Children and Adults with Congenital Heart Disease: A Literature Review. Curr Cardiol Rev. 2024;20(4):e210224227260. doi: 10.2174/011573403X278440240209064408.
citation: Vanreusel I, Segers VFM, Craenenbroeck EV, Berendoncks AV. Coronary Microvascular Dysfunction in Patients with Congenital Heart Disease. Curr Cardiol Rev. 2023;19(4):e190123212886. doi: 10.2174/1573403X19666230119112634.