Health Trials

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

ConditionsAdult Congenital Heart DiseaseCongenital Heart DiseaseSystemic Right VentricleTransposition of the Great ArteriesCongenitally Corrected Transposition of the Great ArteriesFontanSingle VentricleTetralogy of Fallot (TOF)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Congenital heart defect.

Age ≥ 18 years.

Initiated on treatment with an SGLT2i.

Disqualifiers

None

Trial population

All adult patients (≥ 18 years) with congenital heart disease who have been treated with an SGLT2i are eligible for inclusion in the registry.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • SGLT2 inhibitors

    Drug

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

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: ACHD patients treated with SGLT2i1 intervention

Trial outcomes

Primary outcomes

1

Prescription patterns

The primary outcome of this registry is an overview of the prescription patterns of SGLT2i in the ACHD population.

Time frame
Baseline information.

Secondary outcomes

1

Side effects [Safety and Tolerability]

Incidence and specification of any experienced side effects.

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
2

SGLT2i-related complications [Safety and Tolerability]

Incidence and specification of any SGLT2i-related complications.

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
3

SGLT2i discontinuation [Safety and Tolerability]

Incidence of any discontinuation of SGLT2i (including reason for discontinuation).

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.
4

Mortality [Safety and Tolerability]

Mortality and documentation of cause of death.

Time frame
From enrollment through study completion, with an average follow-up duration of 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leiden University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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