Evaluating the effectiveness of SGLT2 inhibitors in adults with congenital heart disease
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 11 sites (Baltimore, Maryland and 10 other locations) |
| Trial ID | NCT06932081 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who do not consent to data collection will not benefit from this study.
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 performed: While SGLT2i have shown effectiveness in conventional heart failure populations, their application in ACHD is still being explored, making this a novel investigation.
Eligibility criteria
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 this trial is running
Baltimore, Maryland and 10 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.