Recruiting

SGLT2i

Sponsor:

Leiden University Medical Center

Code:

NCT06932081

Conditions

Adult Congenital Heart Disease

Congenital Heart Disease

Systemic Right Ventricle

Transposition of the Great Arteries

Congenitally Corrected Transposition of the Great Arteries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SGLT2 inhibitors

Study Details

Brief 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.

Conditions

Adult Congenital Heart Disease

Congenital Heart Disease

Systemic Right Ventricle

Transposition of the Great Arteries

Congenitally Corrected Transposition of the Great Arteries

Study ID

NCT06932081

Start date

Jan 1, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

\- No consent for data collection.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

SGLT2 inhibitors

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

Primary outcome measure

  • Prescription patterns [ Time Frame: Baseline information. ]

Central Contacts and Locations

Central contacts

Ralph M.L. Neijenhuis, MD

+31 71 5262020r.m.l.neijenhuis@lumc.nl

Björn N. Westdorp, MD

+31 71 5262020b.n.westdorp@lumc.nl

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Principal Investigator:

Ari M. Cedars, MD PhD

Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Gruschen R. Veldtman, MBChB FRCP

Mount Sinai Fuster Heart Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Ali Zaidi, MD

More Information

Sponsor

Leiden University Medical Center

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Leiden University Medical Center on 2026-02-13.