Microvascular Dysfunction in Adults with Congenital Heart Disease and the Effect of Exercise Training

University Hospital, Antwerp1 site in 1 country55 target enrollmentJanuary 18, 2021

ConditionsCongenital Heart Defect Congenital Heart Disease Microvascular Dysfunction Exercise Training Oxidative Stress Coronary Microvascular Dysfunction Peripheral Microvascular Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Congenital Heart Defect
Sponsor: University Hospital, Antwerp
Enrollment: 55
Locations: 1
Primary Endpoint: Coronary microvascular function: coronary flow reserve
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 18, 2021

End Date

May 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Antwerp

Responsible Party

Sponsor

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

•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.

Outcomes

Primary Outcomes

Coronary microvascular function: coronary flow reserve

Time Frame: on both study visits (at baseline and at 16 weeks)

The coronary flow reserve (CFR) was measured using pulsed wave Doppler measurements at the mid to distal left anterior descending artery (LAD) in an apical modified 2-chamber view. At baseline and during hyperemia (following a 3-minute period of intravenous adenosine administration at a rate of 140 µg/kg/min), three optimal profiles of peak diastolic Doppler flow velocities were measured, and the results were averaged. CFR was then calculated as the ratio between hyperemic and basal average peak velocities.

Secondary Outcomes

Peripheral microvascular function: reactive hyperemia index(on both study visits (at baseline and at 16 weeks))
Peripheral microvascular function: Framingham modified reactive hyperemia index(on both study visits (at baseline and at 16 weeks))
Carotid arterial wall thickness: carotid intima-media thickness(on both study visits (at baseline and at 16 weeks))
Large artery stiffness: pulse wave velocity(on both study visits (at baseline and at 16 weeks))
Large artery stiffness: augmentation index(on both study visits (at baseline and at 16 weeks))
Inflammation: white blood cell count(on both study visits (at baseline and at 16 weeks))
Inflammation: high-sensitivity C-reactive protein(on both study visits (at baseline and at 16 weeks))
Oxidative stress: superoxide anion radical(on both study visits (at baseline and at 16 weeks))
Left ventricular function: ejection fraction(on both study visits (at baseline and at 16 weeks))
Left ventricular function: global longitudinal strain(on both study visits (at baseline and at 16 weeks))
Right ventricular function: fractional area change(on both study visits (at baseline and at 16 weeks))
Right ventricular function: tricuspid annular plane systolic excursion(on both study visits (at baseline and at 16 weeks))
Right ventricular function: tissue Doppler imaging systolic velocity(on both study visits (at baseline and at 16 weeks))
Right ventricular function: peak systolic global longitudinal strain(on both study visits (at baseline and at 16 weeks))
Quality of life: RAND 36-Item Health Survey 1.0(on both study visits (at baseline and at 16 weeks))
Quality of life: EuroQol visual analogue scale(on both study visits (at baseline and at 16 weeks))
Exercise capacity: percent-predicted peak oxygen consumption(on both study visits (at baseline and at 16 weeks))
Muscle strength: one-repetition maximum(on both study visits (at baseline and at 16 weeks))