NCT06932081

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
5 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2023Dec 2027

Study Start

First participant enrolled

January 1, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

March 2, 2025

Last Update Submit

February 11, 2026

Conditions

Adult Congenital Heart DiseaseCongenital Heart DiseaseSystemic Right VentricleTransposition of the Great ArteriesCongenitally Corrected Transposition of the Great ArteriesFontanSingle VentricleTetralogy of Fallot (TOF)

Keywords

adult congenital heart diseaseACHDcongenital heart diseaseCHDsodium-glucose cotransporter 2 inhibitorsSGLT2iSGLT2heart failureHFtransposition of the great arteriesTGAsystemic right ventriclesRVFontansingle ventricletetralogy of fallotToF

Outcome Measures

Primary Outcomes (1)

  • Prescription patterns

    The primary outcome of this registry is an overview of the prescription patterns of SGLT2i in the ACHD population.

    Baseline information.

Secondary Outcomes (31)

  • Side effects [Safety and Tolerability]

    From enrollment through study completion, with an average follow-up duration of 1 year.

  • SGLT2i-related complications [Safety and Tolerability]

    From enrollment through study completion, with an average follow-up duration of 1 year.

  • SGLT2i discontinuation [Safety and Tolerability]

    From enrollment through study completion, with an average follow-up duration of 1 year.

  • Mortality [Safety and Tolerability]

    From enrollment through study completion, with an average follow-up duration of 1 year.

  • Admissions [Heart Failure-related Efficacy]

    From enrollment through study completion, with an average follow-up duration of 1 year.

  • +26 more secondary outcomes

Study Arms (1)

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.

Drug: SGLT2 inhibitors

Interventions

SGLT2 inhibitorsDRUG

Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.

ACHD patients treated with SGLT2i

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients (≥ 18 years) with congenital heart disease who have been treated with an SGLT2i are eligible for inclusion in the registry.

You may qualify if:

  • Congenital heart defect.
  • Age ≥ 18 years.
  • Initiated on treatment with an SGLT2i.

You may not qualify if:

  • \- No consent for data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mount Sinai Fuster Heart Hospital

New York, New York, 10029, United States

RECRUITING

Heart Center Duisburg (Evangelical Hospital Niederrhein)

Duisburg, Germany

RECRUITING

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2333ZA, 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

Related Publications (5)

  • Neijenhuis RM, Regeer MV, Walker NL, Mertens BJ, Hunter A, Kies P, Swan L, Vliegen HW, MacDonald ST, Zemrak F, Zaidi AN, Cedars AM, Jongbloed MR, Jukema JW, Veldtman GR, Egorova AD. Effect of sodium-glucose cotransporter 2 inhibitors on ventricular function in systemic right ventricular failure. Open Heart. 2025 Jul 21;12(2):e003445. doi: 10.1136/openhrt-2025-003445.

    PMID: 40695536RESULT

  • Neijenhuis RML, Regeer MV, Walker NL, Hunter A, Kies P, Holman ER, Jukema JW, Jongbloed MRM, Veldtman GR, Egorova AD. Echocardiographic effects of sodium-glucose cotransporter 2 inhibitors in single ventricle circulatory failure. Int J Cardiol Congenit Heart Dis. 2025 Jun 21;21:100603. doi: 10.1016/j.ijcchd.2025.100603. eCollection 2025 Sep.

    PMID: 40689152RESULT

  • 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.

    PMID: 38530688RESULT

  • 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.

    PMID: 37435053RESULT

  • 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.

    PMID: 35355435RESULT

MeSH Terms

Conditions

Heart Defects, CongenitalTransposition of Great VesselsCongenitally Corrected Transposition of the Great ArteriesUniventricular HeartTetralogy of FallotHeart Failure

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Anastasia D. Egorova, MD PhD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph M.L. Neijenhuis, MD

CONTACT

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

Björn N. Westdorp, MD

CONTACT

+31 71 5262020b.n.westdorp@lumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 2, 2025

First Posted

April 17, 2025

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

US(3)GB(3)NL(3)DE(1)NO(1)