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

NCT06715137 | Completed

• 1 other identifier: Edge 001475
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Coronary microvascular function: coronary flow reserve

  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.

  on both study visits (at baseline and at 16 weeks)

Secondary Outcomes (18)

• 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)

Study Arms (2)

Exercise arm

EXPERIMENTAL

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.

Behavioral: Exercise training

Conventional care arm

NO INTERVENTION

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.

Interventions

Exercise training BEHAVIORAL

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. For the aerobic training, the patients cycled for 30-45 minutes on an exercise bike at home 3 times a week. During each training session, the heart rate (HR) was continuously recorded using a chest strap and displayed in a smartphone application. The target HR zones were predefined with alternating intervals of intensive and extensive aerobic training. The program followed a progressive structure with the objective of completing 40 minutes of intensive aerobic training after 16 weeks. In the strength training program, 4 dynamic exercises targeting major muscle groups were performed 3 times a week. Every 2 weeks, these exercises were intensified by altering the starting position or adding extra weight.

Also known as: Exercise program, Home-based aerobic and strength exercise program, Training program, Exercise training progam

Exercise arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (5)

• 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.

  PMID: 36552576 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 38000042 BACKGROUND

• 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.

  PMID: 38409710 BACKGROUND

• 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.

  PMID: 36658708 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: January 18, 2021
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)