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

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Microvascular Dysfunction; Exercise Training; Coronary Microvascular Dysfunction; Oxidative Stress; Congenital Heart Defect; Congenital Heart Disease; Peripheral Microvascular Dysfunction

Treatments: Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT06715137

Edge 001475

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 2 patient groups

Exercise arm

Experimental group

Description:

Each participant received a personalized rehabilitation schedule combining aerobic interval cycle training and a dynamic strength exercise program, developed to ensure that the participants met the physical activity guidelines.

Treatment:

Behavioral: Exercise training

Conventional care arm

No Intervention group

Description:

In the conventional care arm, patients did not receive explicit exercise advice but were provided with general information regarding a healthy lifestyle, in accordance with current physical activity guidelines during the first study visit.