Adult Congenital Heart DiseaseACHIEVE-SGLT2iNCT06932081
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
An observational study of Adult Congenital Heart Disease and Congenital Heart Disease, run by Leiden University Medical Center at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle
- What is being tested?
- SGLT2 inhibitors
- How many people
- 400 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 1 Jan 2023to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Congenital heart defect.
- Age ≥ 18 years.
- Initiated on treatment with an SGLT2i.
Who cannot join
- No consent for data collection.
Trial locations and contacts
11 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 5 countries
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Ari M. Cedars, MD PhD
- Recruiting
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Gruschen R. Veldtman, MBChB FRCP
- Recruiting
Mount Sinai Fuster Heart Hospital
New York, New York, 10029
Ali Zaidi, MD
Netherlands3 sites, 3 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam
Berto J. Bouma, MD PhD
- Recruiting
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333ZA
Ralph M.L. Neijenhuis, MD, +31 71 5262020, r.m.l.neijenhuis@lumc.nl
Björn N. Westdorp, MD, +31 71 5262020, b.n.westdorp@lumc.nl
- Recruiting
University Medical Center Utrecht
Utrecht
Heleen B. Van Der Zwaan, MD PhD
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospital of Wales
Cardiff
Simon T. MacDonald, MD DPhil
- Recruiting
Golden Jubilee University National Hospital
Glasgow
Niki L. Walker, MBChB PhD
- Recruiting
Barts Heart Centre
London
Filip Zemrak, MD PhD
Germany1 site, 1 recruiting
- Recruiting
Heart Center Duisburg (Evangelical Hospital Niederrhein)
Duisburg
Paul Hacke, MD
Anas Shihab, MD
North Macedonia1 site, 1 recruiting
- Recruiting
Zan Mitrev Clinic
Skopje
Milka Klinceva, MD PhD
About this study
Official title: Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-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.
Read the detailed description
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.
- Conditions
- Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle, Transposition of the Great Arteries, Congenitally Corrected Transposition of the Great Arteries, Fontan
- Being tested
- SGLT2 inhibitors
- Keywords
- adult congenital heart disease, ACHD, congenital heart disease, CHD, sodium-glucose cotransporter 2 inhibitors, SGLT2i, SGLT2, heart failure, HF, transposition of the great arteries, TGA, systemic right ventricle, sRV, Fontan, single ventricle, tetralogy of fallot, ToF
- Medical subject headings
- Heart Defects, Congenital, Transposition of Great Vessels, Congenitally Corrected Transposition of the Great Arteries, Univentricular Heart, Tetralogy of Fallot, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorsDrug
Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: SGLT2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription patterns
The primary outcome of this registry is an overview of the prescription patterns of SGLT2i in the ACHD population.
Measured: Baseline information.
Secondary outcomes (31)
Side effects [Safety and Tolerability]
Incidence and specification of any experienced side effects.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
SGLT2i-related complications [Safety and Tolerability]
Incidence and specification of any SGLT2i-related complications.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
SGLT2i discontinuation [Safety and Tolerability]
Incidence of any discontinuation of SGLT2i (including reason for discontinuation).
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Mortality [Safety and Tolerability]
Mortality and documentation of cause of death.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Admissions [Heart Failure-related Efficacy]
Documentation of number of hospitalizations, including number of heart failure-related hospitalizations and number of urgent heart failure visits.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - weight [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on weight (kg)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - systolic blood pressure [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on systolic blood pressure (mmHg)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - diastolic blood pressure [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on diastolic blood pressure (mmHg)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - heart rate [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on heart rate (beats per minute)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - saturation [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on oxygen saturation (%)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - sodium [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum sodium (mmol/L)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - potassium [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum potassium (mmol/L)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - creatinine [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum creatinine (µmol/L)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - eGFR [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on estimated glomerular filtration rate (eGFR, ml/min/1.73m2)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - NT-proBNP [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum NT-proBNP (ng/L)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - glucose [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum glucose (mmol/L)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - HbA1c [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on serum HbA1c (mmol/mol Hb)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV function [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on systolic left ventricular (LV) function (categorical: good, mildly reduced, moderately reduced, severely reduced function)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV GLS [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on LV global longitudinal strain (GLS, %) assessed with transthoracic echocardiography
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV FAC [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on LV fractional area change (FAC, %) assessed with transthoracic echocardiography
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV function [Heart Failure-related Efficacy]
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
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV GLS [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on RV GLS (%) assessed with transthoracic echocardiography
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV FAC [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on RV FAC (%) assessed with transthoracic echocardiography
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV S' [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on RV S' (cm/s) assessed with transthoracic echocardiography
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - TAPSE [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on tricuspid annular plane systolic excursion (TAPSE, mm) assessed with transthoracic echocardiography
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - 6MWT [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on exercise parameter 6-minute walk test (6MWT, meters)
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - maximum performance [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on maximum performance (Watt) with bicycle ergometry.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - validity [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on validity (%-predicted of the maximum performance) with bicycle ergometry.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - VO2 max [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on VO2 max (mL/kg/min) with bicycle ergometry.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - %-predicted VO2 max [Heart Failure-related Efficacy]
Evaluation of the longitudinal effect of SGLT2i on %-predicted of VO2 max (% of the VO2 max) with bicycle ergometry.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Concomitant medication changes [Heart Failure-related Efficacy]
Evaluation of the concomitant changes in other heart failure pharmacotherapy.
Measured: From enrollment through study completion, with an average follow-up duration of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Adult Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anastasia D. Egorova, MD, PhD, Leiden University Medical Center
- Investigators
- Anastasia D. Egorova, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932081
- Sponsor's protocol ID
- 2022-068
- Acronym
- ACHIEVE-SGLT2i
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40695536Neijenhuis 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.
PubMed 40689152Neijenhuis 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.
PubMed 38530688Neijenhuis 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.
PubMed 37435053Egorova 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.
PubMed 35355435Neijenhuis RML, Cedars AM, Zaidi A, Torres-Viera G, Mazurek R, Walker NL, Zemrak F, MacDonald ST, Hunter A, Kies P, Bosch L, Swan L, van der Zwaan HB, Jukema JW, Jongbloed MRM, Veldtman GR, Egorova AD. Real-world experience with sodium-glucose cotransporter 2 inhibitors in adults with Fontan circulatory failure. Front Cardiovasc Med. 2026 May 8;13:1771868. doi: 10.3389/fcvm.2026.1771868. eCollection 2026.
PubMed 42181636
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry
- ClinicalTrials.gov ID
- NCT06932081
- Acronym / sponsor ID
- ACHIEVE-SGLT2i / 2022-068
- Conditions
- Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle, Transposition of the Great Arteries, Congenitally Corrected Transposition of the Great Arteries, Fontan
- Keywords
- adult congenital heart disease, ACHD, congenital heart disease, CHD, sodium-glucose cotransporter 2 inhibitors, SGLT2i, SGLT2, heart failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACHD patients treated with SGLT2i | – | Drug: SGLT2 inhibitorsAll participants included in the registry have to have a congenital heart defect, be ≥ 18 years old, and receive (or have received) treatment with SGLT2i. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Congenital heart defect.
- Age ≥ 18 years.
- Initiated on treatment with an SGLT2i.
Key exclusion criteria (1 listed)
- No consent for data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorsTreatment with any type and dose of sodium-glucose cotransporter 2 inhibitor. | Drug | ACHD patients treated with SGLT2i |
Primary outcome
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.
31 secondary outcomes
Side effects [Safety and Tolerability]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
SGLT2i-related complications [Safety and Tolerability]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
SGLT2i discontinuation [Safety and Tolerability]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Mortality [Safety and Tolerability]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Admissions [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - weight [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
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.
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.
Clinical parameters - heart rate [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Clinical parameters - saturation [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - sodium [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - potassium [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - creatinine [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - eGFR [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - NT-proBNP [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - glucose [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Laboratory parameters - HbA1c [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV function [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV GLS [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - LV FAC [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV function [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV GLS [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV FAC [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - RV S' [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Transthoracic echocardiography - TAPSE [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - 6MWT [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - maximum performance [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - validity [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Exercise parameters - VO2 max [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
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.
Concomitant medication changes [Heart Failure-related Efficacy]
Time frame: From enrollment through study completion, with an average follow-up duration of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Results publication: PubMed 40695536Neijenhuis 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.
- Results publication: PubMed 40689152Neijenhuis 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.
- Results publication: PubMed 38530688Neijenhuis 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.
- Results publication: PubMed 37435053Neijenhuis 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.
- Results publication: PubMed 35355435Egorova 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.
- Derived from this study: PubMed 42181636Neijenhuis RML, Cedars AM, Zaidi A, Torres-Viera G, Mazurek R, Walker NL, Zemrak F, MacDonald ST, Hunter A, Kies P, Bosch L, Swan L, van der Zwaan HB, Jukema JW, Jongbloed MRM, Veldtman GR, Egorova AD. Real-world experience with sodium-glucose cotransporter 2 inhibitors in adults with Fontan circulatory failure. Front Cardiovasc Med. 2026 May 8;13:1771868. doi: 10.3389/fcvm.2026.1771868. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anastasia D. Egorova, MD PhD principal investigator
Leiden University Medical Center
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Congenital Heart Disease and Congenital Heart Disease, run by Leiden University Medical Center at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands, United Kingdom, Germany, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ralph M.L. Neijenhuis, MD (+31 71 5262020, r.m.l.neijenhuis@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription patterns (time frame: Baseline information.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932081, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.