Effect of sodium-glucose cotransporter 2 inhibitors on ventricular function in systemic right ventricular failure.
Ralph Ml Neijenhuis, Madelien V Regeer, Niki L Walker...
https://pubmed.ncbi.nlm.nih.gov/40695536Actively Recruiting
Age: 18Years +
All Genders
ID06932081
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry
Led by Leiden University Medical Center · Updated on 2026-02-13
400
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adults with congenital heart disease (ACHD), focusing on how these drugs are prescribed and their safety, tolerability, and possible benefits for heart failure-related outcomes. Heart failure is a leading cause of illness and death in this group, but treatment options are limited. SGLT2i are a new class of medications shown to help in conventional left ventricular heart failure and may work through multiple pathways to improve heart function. This international registry collects real-world data from adult ACHD patients who have been treated with any type and dose of SGLT2i. Data will be gathered from one year before starting the medication up to the most recent follow-up. There are no interventions or changes to care for participants since data collection uses routine clinical records. The registry aims to understand prescription patterns, side effects, discontinuation rates, and heart failure-related clinical and laboratory outcomes. Participants will contribute data from their medical records, including clinical parameters like weight, blood pressure, heart rate, oxygen saturation, laboratory values, echocardiography measurements, and exercise test results. Researchers will monitor safety and tolerability outcomes such as side effects, complications, and mortality over an average follow-up of one year. This study seeks to evaluate the impact of SGLT2i therapy on heart failure progression in ACHD patients through comprehensive real-world observation.
CONDITIONS
Brief Title
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have a congenital heart defect
- Be 18 years of age or older
- Have started treatment with a sodium-glucose cotransporter 2 inhibitor (SGLT2i)
You will not qualify if you...
- Do not consent to data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Approximately 2 years (1 year retrospective and 1 year prospective)
Participants who receive routine care with SGLT2 inhibitors for congenital heart disease are observed. Data are collected from 1 year before starting SGLT2i treatment through an average of 1 year of follow-up after starting treatment to evaluate prescription patterns, safety, tolerability, and heart failure-related outcomes.
Visits as part of routine clinical care
Trial Site Locations
Total: 11 locations
1
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Actively Recruiting
2
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
3
Mount Sinai Fuster Heart Hospital
New York, New York, United States, 10029
Actively Recruiting
4
Heart Center Duisburg (Evangelical Hospital Niederrhein)
Duisburg, Germany
Actively Recruiting
5
Leiden University Medical Center (LUMC)
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
6
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
7
University Medical Center Utrecht
Utrecht, Netherlands
Actively Recruiting
8
Zan Mitrev Clinic
Skopje, North Macedonia
Actively Recruiting
9
University Hospital of Wales
Cardiff, United Kingdom
Actively Recruiting
10
Golden Jubilee University National Hospital
Glasgow, United Kingdom
Actively Recruiting
11
Barts Heart Centre
London, United Kingdom
Actively Recruiting
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Research Team
R
Ralph M.L. Neijenhuis, MD
B
Björn N. Westdorp, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Echocardiographic effects of sodium-glucose cotransporter 2 inhibitors in single ventricle circulatory failure.
Ralph M L Neijenhuis, Madelien V Regeer, Niki L Walker...
https://pubmed.ncbi.nlm.nih.gov/40689152Effect of Sodium-Glucose Cotransporter 2 Inhibitors in Adults With Congenital Heart Disease.
Ralph M L Neijenhuis, Simon T MacDonald, Filip Zemrak...
https://pubmed.ncbi.nlm.nih.gov/38530688The potential of sodium-glucose cotransporter 2 inhibitors for the treatment of systemic right ventricular failure in adults with congenital heart disease.
Ralph M L Neijenhuis, Marieke Nederend, Monique R M Jongbloed...
https://pubmed.ncbi.nlm.nih.gov/37435053The first experience with sodium-glucose cotransporter 2 inhibitor for the treatment of systemic right ventricular failure.
Anastasia D Egorova, Marieke Nederend, Laurens F Tops...
https://pubmed.ncbi.nlm.nih.gov/35355435