Association between sedentary time, physical activity, biochemical markers in the blood (heart and muscles) and heart failure in adults with congenital heart disease: a study protocol of a cross-sectional cohort study in Sweden (the ACHD trial protocol)

Abstract

Introduction: Adults with congenital heart disease (ACHD) are a heterogeneous group with a large variation in the severity of lesions and symptoms. This population has rapidly grown in recent years due to improved surgical and medical treatments. Sedentary time and physical activity (PA) and health among individuals classified with single lesions, for example, shunt defects such as atrial and ventricular septal defects, and patent foramen ovale (PFO) with stroke are less studied. The present study describes the study protocol and examines associations between sedentary time, PA, circulating biomarkers in the blood (heart and muscles) and heart failure. Results have the potential to supply the healthcare system with information if further action to promote cardiovascular health in ACHD is needed.

Methods and analysis: A cross-sectional design will be used with data from the local heart register, Swedish Registry for Congenital Heart Disease in Uppsala, Sweden. Individuals ≥18 years of age with simple congenital heart disease, according to the definition atrial septal defect, ventricle septal defect or PFO as the cause of stroke, will be included.

Outcome measures: Self-reported questionnaire: demographic characteristics, education, the prevalence of diabetes, smoking, ethnicity, self-reported level of sitting time and leisure-time PA/exercise, everyday activities, commuting and degree of symptoms associated with exertion. Blood analyses: blood lipids (total cholesterol, high-density lipoprotein and low-density lipoprotein cholesterol, apolipoprotein A1 and B), creatinine, cystatin-C (eGFR), creatine kinase, myoglobin, high-sensitivity troponin, brain natriuretic peptide, C-reactive protein and glycated haemoglobin. Quantitative methods will be used for statistical analyses.

Ethics and dissemination: The Swedish Ethical Review Authority has approved the study (registration numbers 2022-06525-01 and 2023-02082-02). Results will be disseminated in peer-reviewed journals, research meetings, conferences and possibly patient organisations.

Keywords: Adult cardiology; Congenital heart disease; Cross-Sectional Studies; Primary Prevention; REHABILITATION MEDICINE.

Figure 1. Flowchart describing the inclusion process, data collection and sample strategy. Study sample eligibility (n=340). The anticipated exclusion rate is estimated to be approximately 5%. The local medical heart register, in Uppsala, Sweden, will be used to identify eligible individuals.