At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SGLT2 inhibitors (drug)
- How long the study runs
- Study runs about 59 months (dates as stated)
- About the drug or intervention
- SGLT2 inhibitors — drug: Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.
- Patient visit burden
- Not specified by the sponsor
In plain English
This registry collects information from adults born with a heart problem (called congenital heart disease) who have started taking a type of medicine called an SGLT2i (sodium-glucose co-transporter 2 inhibitor). The study team wants to find out how well this medicine works in this group of people. It includes people with conditions such as transposition of the great arteries (TGA), congenitally corrected transposition of the great arteries, a single ventricle, Fontan circulation, a systemic right ventricle and tetralogy of Fallot (TOF), and it is run by Leiden University Medical Center.
Who can take part
- Adults aged 18 or over
- People born with a heart problem (a congenital heart defect)
- People who have started taking an SGLT2i (sodium-glucose co-transporter 2 inhibitor) medicine
Who may not be able to
- People who do not agree (give consent) for their information to be collected
What taking part involves
- • Taking an SGLT2i (sodium-glucose co-transporter 2 inhibitor) medicine, which you must have already started to join
- • Letting the study team collect your health information for the registry
Time commitment: Not stated — ask the trial team how long it lasts, whether any visits are needed, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 400
- Started
- 2023-01-01
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for adult congenital heart disease
- • Clinical study - 400 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with adult congenital heart disease
Where?
- • Cardiff - University Hospital of Wales
- • Glasgow - Golden Jubilee University National Hospital
- • London - Barts Heart Centre
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Congenital heart defect.
- ✓Age ≥ 18 years.
- ✓Initiated on treatment with an SGLT2i.
Who cannot take part
- ✗\- No consent for data collection.
See the full criteria
Where Is This Study? (3 UK sites)
University Hospital of Wales
Cardiff, United Kingdom
Golden Jubilee University National Hospital
Glasgow, United Kingdom
Barts Heart Centre
London, United Kingdom
How to Get in Touch
Ralph M.L. Neijenhuis, MD
Sponsor contactCONTACT
Björn N. Westdorp, MD
Sponsor contactCONTACT