RecruitingOBSERVATIONAL

Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry

This international study is gathering information on a new type of medicine called SGLT2 inhibitors. These medicines are being used in adults who were born with heart conditions (adult congenital heart disease, or ACHD). Heart failure is a big problem for many people with ACHD, and there aren't many specific treatments. While SGLT2 inhibitors have shown promise for other types of heart failure, their effects in ACHD are still being explored. This study aims to understand how widely these medicines are prescribed, if they are safe and well-tolerated, and if they can help improve symptoms of heart failure in this specific group of patients. It's a 'real-world' study, meaning it looks at information from routine patient care.

At a glance

Status

Recruiting

Sponsor

Leiden University Medical Center

Enrolment target

400

Start

01 Jan 2023

Estimated completion

31 Dec 2027

Adult Congenital Heart Disease Congenital Heart Disease Systemic Right Ventricle Transposition of the Great Arteries Congenitally Corrected Transposition of the Great Arteries Fontan Single Ventricle Tetralogy of Fallot (TOF)

What is this study about?

If you are an adult living with a heart condition you were born with, you might know that heart failure can be a common and serious problem. Doctors are always looking for new and better ways to help people manage their heart health. Recently, a type of medicine called SGLT2 inhibitors has shown good results in treating other forms of heart failure. These medicines work in several ways to support the heart, for example, by helping to reduce strain and improve how the heart works.

Because of these promising results, doctors want to find out if SGLT2 inhibitors could also be helpful for adults with congenital heart disease (ACHD). This study is an international effort to gather information from many different hospitals and clinics around the world. The goal is to see how these medicines are currently being used in ACHD patients.

Researchers will be looking closely at how often SGLT2 inhibitors are prescribed, if people experience any side effects (safety and tolerability), and if the medicines seem to have a positive effect on heart failure. By collecting this 'real-world' information, the study hopes to learn more about the best ways to use these treatments to improve the health and well-being of people with ACHD.

Key takeaways

It's an international study about adults with heart conditions they were born with.
It looks at a medicine called SGLT2 inhibitors and how it helps heart failure.
The study gathers information from existing medical records, no extra tests.
It aims to improve understanding of safe and effective treatments for congenital heart disease.
Your data could help many other patients in the future.

Who may be eligible?

To be included in this study, you need to meet a few simple criteria. First, you must have a heart condition that you were born with. Second, you need to be 18 years old or older. Finally, you must have already started taking an SGLT2 inhibitor medication as part of your regular medical care.

This study is for people who are already being treated with this specific medication. You wouldn't start taking the medicine specifically for this project. The main reason someone would not be included is if they don't agree for their medical information to be used for the study.

Quick self-check

I have a heart condition that I was born with.
I am 18 years old or older.
I am currently taking an SGLT2 inhibitor medicine.
I am comfortable with my medical records being used for research (anonymously).

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study is very straightforward because it uses information that is already collected during your normal doctor visits. There are no extra appointments, tests, or medication-taking that you need to do specifically for this study. Researchers will simply look at your existing medical records from your doctors. They will gather information from about one year before you started taking the SGLT2 inhibitor medication up to your most recent follow-up appointment. This allows them to see how your health changed after you started the medication. The total time frame for the data collection will depend on how long you've been on the medication and have been seen by your doctor.

Potential risks and benefits

Since this study only involves reviewing existing medical records, there are no direct physical risks to you. Your personal information will be kept private and secure. The main benefit is that your anonymised data could help doctors worldwide understand more about how SGLT2 inhibitors work for people with congenital heart disease, potentially improving care for many others in the future. You have the right to withdraw your consent for your data to be used in the study at any time, without it affecting your medical care.

Locations (11)

Johns Hopkins University
Baltimore, United States· Recruiting
Helen DeVos Children's Hospital
Grand Rapids, United States· Recruiting
Mount Sinai Fuster Heart Hospital
New York, United States· Recruiting
Heart Center Duisburg (Evangelical Hospital Niederrhein)
Duisburg, Germany· Recruiting
Leiden University Medical Center (LUMC)
Leiden, Netherlands· Recruiting
Amsterdam University Medical Center
Amsterdam, Netherlands· Recruiting
University Medical Center Utrecht
Utrecht, Netherlands· Recruiting
Zan Mitrev Clinic
Skopje, North Macedonia· Recruiting
University Hospital of Wales
Cardiff, United Kingdom· Recruiting
Golden Jubilee University National Hospital
Glasgow, United Kingdom· Recruiting
Barts Heart Centre
London, United Kingdom· Recruiting

Common questions

What is an SGLT2 inhibitor?

It's a type of medicine that has been found to help people with certain heart conditions, including heart failure. Doctors are now seeing how it works for those born with heart problems.

Do I need to take new medication for this study?

No, this study is only for people who are already taking SGLT2 inhibitors as part of their regular medical care. You won't start new medicine just for this project.

Will I have extra doctor appointments?

No, there are no extra appointments. The study uses information from your usual check-ups and medical records.

Will my doctors know I'm part of the study?

Your doctors may be part of the hospital team contributing data, but your personal information will be kept private and secure. Your medical care will not be affected.

What will happen with my personal information?

Your personal details will be kept confidential. Researchers will look at your health information in a way that doesn't identify you specifically, for research purposes only.

How to find out more

Ralph M.L. Neijenhuis, MD

r.m.l.neijenhuis@lumc.nl +31 71 5262020 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.