International Registry Evaluating Sodium-Glucose Cotransporter 2 Inhibitors SGLT2i in Adults with Congenital Heart Disease
Led by Leiden University Medical Center · Updated on 2026-02-13
400
Participants Needed
11
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the use of sodium-glucose cotransporter 2 inhibitors SGLT2i in adults with congenital heart disease ACHD, focusing on how these drugs are prescribed and their safety, tolerability, and possible benefits for heart failure-related outcomes. Heart failure is a leading cause of illness and death in this group, but treatment options are limited. SGLT2i are a new class of medications shown to help in conventional left ventricular heart failure and may work through multiple pathways to improve heart function.
This international registry collects real-world data from adult ACHD patients who have been treated with any type and dose of SGLT2i. Data will be gathered from one year before starting the medication up to the most recent follow-up. There are no interventions or changes to care for participants since data collection uses routine clinical records. The registry aims to understand prescription patterns, side effects, discontinuation rates, and heart failure-related clinical and laboratory outcomes.
Participants will contribute data from their medical records, including clinical parameters like weight, blood pressure, heart rate, oxygen saturation, laboratory values, echocardiography measurements, and exercise test results. Researchers will monitor safety and tolerability outcomes such as side effects, complications, and mortality over an average follow-up of one year. This study seeks to evaluate the impact of SGLT2i therapy on heart failure progression in ACHD patients through comprehensive real-world observation.
CONDITIONS
Brief Title
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
Research Team
R
Ralph M.L. Neijenhuis, MD
B
Björn N. Westdorp, MD
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Have started treatment with a sodium-glucose cotransporter 2 inhibitor (SGLT2i)
You will not qualify if you...
Do not consent to data collection
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Approximately 2 years (1 year retrospective and 1 year prospective)
Participants who receive routine care with SGLT2 inhibitors for congenital heart disease are observed. Data are collected from 1 year before starting SGLT2i treatment through an average of 1 year of follow-up after starting treatment to evaluate prescription patterns, safety, tolerability, and heart failure-related outcomes.
Visits as part of routine clinical care
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The potential of sodium-glucose cotransporter 2 inhibitors for the treatment of systemic right ventricular failure in adults with congenital heart disease.
Ralph M L Neijenhuis, Marieke Nederend, Monique R M Jongbloed...