This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.
In the adult congenital heart disease (ACHD) population, heart failure currently represents the main cause of morbidity and mortality. The etiology of ACHD-related heart failure is heterogenous, and there is limited evidence for pharmacological treatment options for this population. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a novel pillar in the treatment of conventional LV heart failure. SGLT2i have been shown to reduce the risk of worsening heart failure and cardiovascular-related death in patients with LV heart failure. While the exact mechanisms of action are still to be elucidated, SGLT2i seem to address heart failure by targeting several pathways. These include but are not limited to; a decrease in renin-angiotensin and sympathetic nervous system activation, a decrease in pressure overload-induced myocardial fibrosis, reverse cardiac remodeling, and improvement in myocardial energetics. Given the compelling evidence on the effectiveness of SGLT2i over a broad range of cardiac dysfunction and initial promising reports of its utilization in the field of ACHD, SGLT2i deserve further exploration in the group of ACHD patients. This real-world, international registry aims to evaluate the current experience with SGLT2i in ACHD patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes. Project design: Data of all ACHD patients who were started on an SGLT2i will be collected in a real-world, international registry. Only data resulting from routine clinical care will be collected from the electronic health records at the participating centers, and participants will not undergo any interventions for this project. Data will be collected from 1 year before starting with the SGLT2i to most recent follow-up after starting with the SGLT2i, to evaluate if SGLT2i therapy halts the progression of clinical deterioration in ACHD patients with heart failure and can improve heart failure-related outcomes.
Study Type
OBSERVATIONAL
Enrollment
400
Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.
Johns Hopkins University
Baltimore, Maryland, United States
RECRUITINGHelen DeVos Children's Hospital
Grand Rapids, Michigan, United States
RECRUITINGMount Sinai Fuster Heart Hospital
New York, New York, United States
RECRUITINGHeart Center Duisburg (Evangelical Hospital Niederrhein)
Duisburg, Germany
RECRUITINGLeiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands
RECRUITINGAmsterdam University Medical Center
Amsterdam, Netherlands
RECRUITINGUniversity Medical Center Utrecht
Utrecht, Netherlands
RECRUITINGZan Mitrev Clinic
Skopje, North Macedonia
RECRUITINGUniversity Hospital of Wales
Cardiff, United Kingdom
RECRUITINGGolden Jubilee University National Hospital
Glasgow, United Kingdom
RECRUITING...and 1 more locations
Prescription patterns
The primary outcome of this registry is an overview of the prescription patterns of SGLT2i in the ACHD population.
Time frame: Baseline information.
Side effects [Safety and Tolerability]
Incidence and specification of any experienced side effects.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
SGLT2i-related complications [Safety and Tolerability]
Incidence and specification of any SGLT2i-related complications.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
SGLT2i discontinuation [Safety and Tolerability]
Incidence of any discontinuation of SGLT2i (including reason for discontinuation).
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Mortality [Safety and Tolerability]
Mortality and documentation of cause of death.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Admissions [Heart Failure-related Efficacy]
Documentation of number of hospitalizations, including number of heart failure-related hospitalizations and number of urgent heart failure visits.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - weight [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on weight (kg)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - systolic blood pressure [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on systolic blood pressure (mmHg)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - diastolic blood pressure [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on diastolic blood pressure (mmHg)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - heart rate [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on heart rate (beats per minute)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - saturation [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on oxygen saturation (%)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - sodium [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum sodium (mmol/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - potassium [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum potassium (mmol/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - creatinine [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum creatinine (µmol/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - eGFR [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on estimated glomerular filtration rate (eGFR, ml/min/1.73m2)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - NT-proBNP [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum NT-proBNP (ng/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - glucose [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum glucose (mmol/L)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - HbA1c [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum HbA1c (mmol/mol Hb)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV function [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on systolic left ventricular (LV) function (categorical: good, mildly reduced, moderately reduced, severely reduced function)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV GLS [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on LV global longitudinal strain (GLS, %) assessed with transthoracic echocardiography
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV FAC [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on LV fractional area change (FAC, %) assessed with transthoracic echocardiography
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV function [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on systolic right ventricular (RV) function (categorical: good, mildly reduced, moderately reduced, severely reduced function) assessed with transthoracic echocardiography
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV GLS [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on RV GLS (%) assessed with transthoracic echocardiography
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV FAC [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on RV FAC (%) assessed with transthoracic echocardiography
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV S' [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on RV S' (cm/s) assessed with transthoracic echocardiography
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - TAPSE [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on tricuspid annular plane systolic excursion (TAPSE, mm) assessed with transthoracic echocardiography
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - 6MWT [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on exercise parameter 6-minute walk test (6MWT, meters)
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - maximum performance [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on maximum performance (Watt) with bicycle ergometry.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - validity [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on validity (%-predicted of the maximum performance) with bicycle ergometry.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - VO2 max [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on VO2 max (mL/kg/min) with bicycle ergometry.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - %-predicted VO2 max [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on %-predicted of VO2 max (% of the VO2 max) with bicycle ergometry.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Concomitant medication changes [Heart Failure-related Efficacy]
Evaluation of the concomitant changes in other heart failure pharmacotherapy.
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
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