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NCT Number: NCT06932081

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

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.

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Key information

Conditions

Adult Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Congenitally Corrected Transposition of the Great Arteries Fontan Heart Defects, Congenital Heart Diseases Heart Failure Single Ventricle Systemic Right Ventricle Tetralogy of Fallot Tetralogy of Fallot (TOF) Transposition of Great Vessels Transposition of the Great Arteries Univentricular Heart

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Duisburg (Evangelical Hospital Niederrhein), Duisburg, Germany

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About this study

In the adult congenital heart disease (ACHD) population, heart failure currently represents the main cause of morbidity and mortality. The etiology of ACHD-related heart failure is heterogenous, and there is limited evidence for pharmacological treatment options for this population.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No consent for data collection.

Treatment and study plan

SGLT2 inhibitors

Drug

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

Primary outcomes

  1. Prescription patterns

    Time frame: Baseline information.

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

Secondary outcomes

  1. Side effects [Safety and Tolerability]

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

    Incidence and specification of any experienced side effects.

  2. SGLT2i-related complications [Safety and Tolerability]

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

    Incidence and specification of any SGLT2i-related complications.

  3. SGLT2i discontinuation [Safety and Tolerability]

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

    Incidence of any discontinuation of SGLT2i (including reason for discontinuation).

  4. Mortality [Safety and Tolerability]

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

    Mortality and documentation of cause of death.

  5. Admissions [Heart Failure-related Efficacy]

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

    Documentation of number of hospitalizations, including number of heart failure-related hospitalizations and number of urgent heart failure visits.

  6. Clinical parameters - weight [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on weight (kg)

  7. Clinical parameters - systolic blood pressure [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on systolic blood pressure (mmHg)

  8. Clinical parameters - diastolic blood pressure [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on diastolic blood pressure (mmHg)

  9. Clinical parameters - heart rate [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on heart rate (beats per minute)

  10. Clinical parameters - saturation [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on oxygen saturation (%)

  11. Laboratory parameters - sodium [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on serum sodium (mmol/L)

  12. Laboratory parameters - potassium [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on serum potassium (mmol/L)

  13. Laboratory parameters - creatinine [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on serum creatinine (µmol/L)

  14. Laboratory parameters - eGFR [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on estimated glomerular filtration rate (eGFR, ml/min/1.73m2)

  15. Laboratory parameters - NT-proBNP [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on serum NT-proBNP (ng/L)

  16. Laboratory parameters - glucose [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on serum glucose (mmol/L)

  17. Laboratory parameters - HbA1c [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on serum HbA1c (mmol/mol Hb)

  18. Transthoracic echocardiography - LV function [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on systolic left ventricular (LV) function (categorical: good, mildly reduced, moderately reduced, severely reduced function)

  19. Transthoracic echocardiography - LV GLS [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on LV global longitudinal strain (GLS, %) assessed with transthoracic echocardiography

  20. Transthoracic echocardiography - LV FAC [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on LV fractional area change (FAC, %) assessed with transthoracic echocardiography

  21. Transthoracic echocardiography - RV function [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on systolic right ventricular (RV) function (categorical: good, mildly reduced, moderately reduced, severely reduced function) assessed with transthoracic echocardiography

  22. Transthoracic echocardiography - RV GLS [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on RV GLS (%) assessed with transthoracic echocardiography

  23. Transthoracic echocardiography - RV FAC [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on RV FAC (%) assessed with transthoracic echocardiography

  24. Transthoracic echocardiography - RV S' [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on RV S' (cm/s) assessed with transthoracic echocardiography

  25. Transthoracic echocardiography - TAPSE [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on tricuspid annular plane systolic excursion (TAPSE, mm) assessed with transthoracic echocardiography

  26. Exercise parameters - 6MWT [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on exercise parameter 6-minute walk test (6MWT, meters)

  27. Exercise parameters - maximum performance [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on maximum performance (Watt) with bicycle ergometry.

  28. Exercise parameters - validity [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on validity (%-predicted of the maximum performance) with bicycle ergometry.

  29. Exercise parameters - VO2 max [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on VO2 max (mL/kg/min) with bicycle ergometry.

  30. Exercise parameters - %-predicted VO2 max [Heart Failure-related Efficacy]

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

    Evaluation of the longitudinal effect of SGLT2i on %-predicted of VO2 max (% of the VO2 max) with bicycle ergometry.

  31. Concomitant medication changes [Heart Failure-related Efficacy]

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

    Evaluation of the concomitant changes in other heart failure pharmacotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Björn N. Westdorp, MD

CONTACT

[email protected]

+31 71 5262020

Ralph M.L. Neijenhuis, MD

CONTACT

[email protected]

+31 71 5262020

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry

Acronym: ACHIEVE-SGLT2i

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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