Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 11
- Primary Endpoint
- Prescription patterns
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Congenital heart defect.
- •Age ≥ 18 years.
- •Initiated on treatment with an SGLT2i.
Exclusion Criteria
- •- No consent for data collection.
Arms & Interventions
ACHD patients treated with SGLT2i
All participants included in the registry have to have a congenital heart defect, be ≥ 18 years old, and receive (or have received) treatment with SGLT2i.
Intervention: SGLT2 inhibitors (Drug)
Outcomes
Primary Outcomes
Prescription patterns
Time Frame: Baseline information.
The primary outcome of this registry is an overview of the prescription patterns of SGLT2i in the ACHD population.
Secondary Outcomes
- Clinical parameters - diastolic blood pressure [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - heart rate [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - saturation [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - sodium [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - potassium [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - creatinine [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - eGFR [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - NT-proBNP [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - glucose [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - LV FAC [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV function [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV GLS [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV FAC [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - RV S' [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - TAPSE [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - 6MWT [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - maximum performance [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - validity [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - VO2 max [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Exercise parameters - %-predicted VO2 max [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Concomitant medication changes [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Side effects [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- SGLT2i-related complications [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- SGLT2i discontinuation [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Mortality [Safety and Tolerability](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Admissions [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - weight [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Clinical parameters - systolic blood pressure [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Laboratory parameters - HbA1c [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - LV function [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
- Transthoracic echocardiography - LV GLS [Heart Failure-related Efficacy](From enrollment through study completion, with an average follow-up duration of 1 year.)
Investigators
Anastasia D. Egorova, MD, PhD
Principal Investigator
Leiden University Medical Center