Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
NCT ID: NCT06932081
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-01-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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ACHD patients treated with SGLT2i
All participants included in the registry have to have a congenital heart defect, be ≥ 18 years old, and receive (or have received) treatment with SGLT2i.
SGLT2 inhibitors
Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.
Interventions
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SGLT2 inhibitors
Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* Initiated on treatment with an SGLT2i.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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aegorova
Principal Investigator
Principal Investigators
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Anastasia D. Egorova, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Mount Sinai Fuster Heart Hospital
New York, New York, United States
Leiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands
Amsterdam University Medical Center
Amsterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Zan Mitrev Clinic
Skopje, , North Macedonia
University Hospital of Wales
Cardiff, , United Kingdom
Golden Jubilee University National Hospital
Glasgow, , United Kingdom
Barts Heart Centre
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Neijenhuis RML, MacDonald ST, Zemrak F, Mertens BJA, Dinsdale A, Hunter A, Walker NL, Swan L, Reddy S, Rotmans JI, Jukema JW, Jongbloed MRM, Veldtman GR, Egorova AD. Effect of Sodium-Glucose Cotransporter 2 Inhibitors in Adults With Congenital Heart Disease. J Am Coll Cardiol. 2024 Apr 16;83(15):1403-1414. doi: 10.1016/j.jacc.2024.02.017. Epub 2024 Mar 25.
Neijenhuis RML, Nederend M, Jongbloed MRM, Kies P, Rotmans JI, Vliegen HW, Jukema JW, Egorova AD. The potential of sodium-glucose cotransporter 2 inhibitors for the treatment of systemic right ventricular failure in adults with congenital heart disease. Front Cardiovasc Med. 2023 Jun 26;10:1093201. doi: 10.3389/fcvm.2023.1093201. eCollection 2023.
Egorova AD, Nederend M, Tops LF, Vliegen HW, Jongbloed MRM, Kies P. The first experience with sodium-glucose cotransporter 2 inhibitor for the treatment of systemic right ventricular failure. ESC Heart Fail. 2022 Jun;9(3):2007-2012. doi: 10.1002/ehf2.13871. Epub 2022 Mar 30.
Other Identifiers
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2022-068
Identifier Type: -
Identifier Source: org_study_id
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