Clinical trial Recruiting at 11 sites Observational Ages 18 and up

Evaluating the effectiveness of SGLT2 inhibitors in adults with congenital heart disease

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

Run by Leiden University Medical Center · NCT06932081 · Data updated 2026-11-12

This study is trying to see if a new type of diabetes medication can help adults with congenital heart disease feel better and manage their heart failure symptoms.

More Congenital Heart Disease trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorLeiden University Medical Center
Academic / other
Locations11 sites (Baltimore, Maryland and 10 other locations)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedFebruary 13, 2026
Trial IDNCT06932081 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 years or older with a congenital heart defect who have been initiated on treatment with an SGLT2i.

Probably not a fit

Patients who do not consent to data collection will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international registry collects real-world data on the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients. It aims to assess prescription patterns, safety, tolerability, and the potential benefits of SGLT2i on heart failure-related outcomes. Given the high morbidity and mortality associated with heart failure in ACHD, this study seeks to provide insights into a novel treatment approach that has shown promise in other heart failure populations.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with adult congenital heart disease experiencing heart failure.

How similar studies have gone: While SGLT2i have shown effectiveness in conventional heart failure populations, their application in ACHD is still being explored, making this a novel investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

\- No consent for data collection.

Where it's running

  • Johns Hopkins University
    Baltimore, Maryland, United States
    Recruiting
  • Helen DeVos Children's Hospital
    Grand Rapids, Michigan, United States
    Recruiting
  • Mount Sinai Fuster Heart Hospital
    New York, New York, United States
    Recruiting
  • Heart Center Duisburg (Evangelical Hospital Niederrhein)
    Duisburg, Germany
    Recruiting
  • Leiden University Medical Center (LUMC)
    Leiden, South Holland, Netherlands
    Recruiting
  • Amsterdam University Medical Center
    Amsterdam, Netherlands
    Recruiting
Show 5 more locations
  • 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

Study contacts

  • Principal investigator: Anastasia D. Egorova, MD PhD — Leiden University Medical Center
  • Study coordinator: Ralph M.L. Neijenhuis, MD
  • Email: r.m.l.neijenhuis@lumc.nl
  • Phone: +31 71 5262020

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.