Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Leiden University Medical Center
Study ID
NCT06932081
Status
Recruiting
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Conditions

  • Adult Congenital Heart Disease
  • Congenital Heart Disease
  • Congenitally Corrected Transposition of the Great Arteries
  • Fontan
  • Single Ventricle
  • Systemic Right Ventricle
  • Tetralogy of Fallot (TOF)
  • Transposition of the Great Arteries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SGLT2 inhibitors — DRUG
    Treatment with any type and dose of sodium-glucose cotransporter 2 inhibitor.

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Prescription patterns [ Time Frame: Baseline information. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205
Ari M. Cedars, MD PhD (PRINCIPAL_INVESTIGATOR)
Helen DeVos Children's HospitalGrand RapidsMichigan49503
Gruschen R. Veldtman, MBChB FRCP (PRINCIPAL_INVESTIGATOR)
Mount Sinai Fuster Heart HospitalNew YorkNew York10029
Ali Zaidi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University· Baltimore, MDHelen DeVos Children's Hospital· Grand Rapids, MIMount Sinai Fuster Heart Hospital· New York, NY

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