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

February 11, 2026 updated by: Anastasia D. Egorova, MD, PhD, Leiden University Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Duisburg, Germany
        • Recruiting
        • Heart Center Duisburg (Evangelical Hospital Niederrhein)
        • Principal Investigator:
          • Paul Hacke, MD
        • Sub-Investigator:
          • Anas Shihab, MD
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam University Medical Center
        • Principal Investigator:
          • Berto J. Bouma, MD PhD
      • Utrecht, Netherlands
        • Recruiting
        • University Medical Center Utrecht
        • Principal Investigator:
          • Heleen B. Van Der Zwaan, MD PhD
    • South Holland
      • Leiden, South Holland, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center (LUMC)
        • Contact:
        • Sub-Investigator:
          • Ralph M.L. Neijenhuis, MD
        • Contact:
        • Principal Investigator:
          • Anastasia D. Egorova, MD PhD
        • Sub-Investigator:
          • Björn N. Westdorp, MD
  • North Macedonia
      • Skopje, North Macedonia
        • Recruiting
        • Zan Mitrev Clinic
        • Principal Investigator:
          • Milka Klinceva, MD PhD
  • United Kingdom
      • Cardiff, United Kingdom
        • Recruiting
        • University Hospital of Wales
        • Principal Investigator:
          • Simon T. MacDonald, MD DPhil
      • Glasgow, United Kingdom
        • Recruiting
        • Golden Jubilee University National Hospital
        • Principal Investigator:
          • Niki L. Walker, MBChB PhD
      • London, United Kingdom
        • Recruiting
        • Barts Heart Centre
        • Principal Investigator:
          • Filip Zemrak, MD PhD
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Ari M. Cedars, MD PhD
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital
        • Principal Investigator:
          • Gruschen R. Veldtman, MBChB FRCP
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Fuster Heart Hospital
        • Principal Investigator:
          • Ali Zaidi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

- No consent for data collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline information.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Incidence and specification of any SGLT2i-related complications.
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.
Incidence of any discontinuation of SGLT2i (including reason for discontinuation).
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.
Mortality and documentation of cause of death.
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.
Documentation of number of hospitalizations, including number of heart failure-related hospitalizations and number of urgent heart failure visits.
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.
Evaluation of the longitudinal effect of SGLT2i on weight (kg)
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.
Evaluation of the longitudinal effect of SGLT2i on systolic blood pressure (mmHg)
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.
Evaluation of the longitudinal effect of SGLT2i on diastolic blood pressure (mmHg)
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.
Evaluation of the longitudinal effect of SGLT2i on heart rate (beats per minute)
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.
Evaluation of the longitudinal effect of SGLT2i on oxygen saturation (%)
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.
Evaluation of the longitudinal effect of SGLT2i on serum sodium (mmol/L)
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.
Evaluation of the longitudinal effect of SGLT2i on serum potassium (mmol/L)
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.
Evaluation of the longitudinal effect of SGLT2i on serum creatinine (µmol/L)
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.
Evaluation of the longitudinal effect of SGLT2i on estimated glomerular filtration rate (eGFR, ml/min/1.73m2)
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.
Evaluation of the longitudinal effect of SGLT2i on serum NT-proBNP (ng/L)
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.
Evaluation of the longitudinal effect of SGLT2i on serum glucose (mmol/L)
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.
Evaluation of the longitudinal effect of SGLT2i on serum HbA1c (mmol/mol Hb)
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.
Evaluation of the longitudinal effect of SGLT2i on systolic left ventricular (LV) function (categorical: good, mildly reduced, moderately reduced, severely reduced function)
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.
Evaluation of the longitudinal effect of SGLT2i on LV global longitudinal strain (GLS, %) assessed with transthoracic echocardiography
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.
Evaluation of the longitudinal effect of SGLT2i on LV fractional area change (FAC, %) assessed with transthoracic echocardiography
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.
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
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.
Evaluation of the longitudinal effect of SGLT2i on RV GLS (%) assessed with transthoracic echocardiography
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.
Evaluation of the longitudinal effect of SGLT2i on RV FAC (%) assessed with transthoracic echocardiography
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.
Evaluation of the longitudinal effect of SGLT2i on RV S' (cm/s) assessed with transthoracic echocardiography
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.
Evaluation of the longitudinal effect of SGLT2i on tricuspid annular plane systolic excursion (TAPSE, mm) assessed with transthoracic echocardiography
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.
Evaluation of the longitudinal effect of SGLT2i on exercise parameter 6-minute walk test (6MWT, meters)
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.
Evaluation of the longitudinal effect of SGLT2i on maximum performance (Watt) with bicycle ergometry.
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.
Evaluation of the longitudinal effect of SGLT2i on validity (%-predicted of the maximum performance) with bicycle ergometry.
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.
Evaluation of the longitudinal effect of SGLT2i on VO2 max (mL/kg/min) with bicycle ergometry.
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.
Evaluation of the longitudinal effect of SGLT2i on %-predicted of VO2 max (% of the VO2 max) with bicycle ergometry.
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.
Evaluation of the concomitant changes in other heart failure pharmacotherapy.
From enrollment through study completion, with an average follow-up duration of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Investigators

  • Principal Investigator: Anastasia D. Egorova, MD PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 2, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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