Evaluating the effectiveness of SGLT2 inhibitors in adults with congenital heart disease
Official title: Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry
Run by Leiden University Medical Center · NCT06932081 · Data updated 2026-11-12
This study is trying to see if a new type of diabetes medication can help adults with congenital heart disease feel better and manage their heart failure symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 11 sites (Baltimore, Maryland and 10 other locations) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT06932081 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 years or older with a congenital heart defect who have been initiated on treatment with an SGLT2i.
✕Probably not a fit
Patients who do not consent to data collection will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This international registry collects real-world data on the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients. It aims to assess prescription patterns, safety, tolerability, and the potential benefits of SGLT2i on heart failure-related outcomes. Given the high morbidity and mortality associated with heart failure in ACHD, this study seeks to provide insights into a novel treatment approach that has shown promise in other heart failure populations.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with adult congenital heart disease experiencing heart failure.
How similar studies have gone: While SGLT2i have shown effectiveness in conventional heart failure populations, their application in ACHD is still being explored, making this a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Congenital heart defect. * Age ≥ 18 years. * Initiated on treatment with an SGLT2i. Exclusion Criteria: \- No consent for data collection.
Where it's running
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Johns Hopkins University
Baltimore, Maryland, United States Recruiting -
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States Recruiting -
Mount Sinai Fuster Heart Hospital
New York, New York, United States Recruiting -
Heart Center Duisburg (Evangelical Hospital Niederrhein)
Duisburg, Germany Recruiting -
Leiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands Recruiting -
Amsterdam University Medical Center
Amsterdam, Netherlands Recruiting
Show 5 more locations
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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
Study contacts
- Principal investigator: Anastasia D. Egorova, MD PhD — Leiden University Medical Center
- Study coordinator: Ralph M.L. Neijenhuis, MD
- Email: r.m.l.neijenhuis@lumc.nl
- Phone: +31 71 5262020
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.